Recalling Firm
Zions RX Formulations Services LLC dba RX Formuations Serv.
ErgoSafe Product LLC dba Prism Medical Services
Central Purchasing LLC DBA Harbor Freight Tools

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.
US: Nationwide (AR, AZ, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MT, NC, NJ, NM, NV, OH, OK, OR, PA, SC, TX, WA, WI, WV) + Puerto Rico
USA Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, ON, OR, PA, SC, TN, TX, VA, VT, WA, WI Canada - one consignee, Energizer (recalling firm's) company store
Distributed in the states of CA, FL, NJ, TX, and NY.
Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
USA Nationwide Distribution in the states of WI and NY.
USA Nationwide Distribution including Canada
Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Worldwide distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
USA (nationwide) Distribution including Canada
Product was shipped to the following states: AZ, IA, IL, IN, MI, MN & WI.
Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CA, CT, IA, IL, IN, GA, KS, MI, MN, MO, NJ, OH, TX, WI,
USA Nationwide Distribution including San Juan PR
USA Nationwide Distribution in the states of: CA, CO, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, NO, NE,NH,NY, ND,OH, OK, OR, PA , SD, TX, WI.
USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.
USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
Worldwide Distribution - USA (nationwide) including the countries of: ARGENTINA AUSTRALIA AUSTRIA BELGIUM CANADA CHINA CZECH REPUBLIC DENMARK FRANCE GERMANY ITALY LATVIA NETHERLANDS NEW ZEALAND NORWAY PHILIPPINES PORTUGAL SOUTH KOREA SPAIN SWITZERLAND THAILAND TURKEY and UNITED KINGDOM.

Product Description
Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging).
''CHAMPION LAMB TEXTURIZED B30 MEDICATED For GROWING AND FINISHING SHEEP***'' Product Code 6701
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Prego Italian Sauce Traditional, NET WT. 24 OZ (1 LB. 80 Z.)(680 g) in glass jars.
Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178.
Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
St. Mary's River Smokehouses Oven Smoked Atlantic Salmon Stix, Chili Mango Flavor
Evolution fresh Organic sweet Greens and Ginger, 15.2 fluid-ounce bottle, 6 bottles/case, UPC code is 762357378927.
1/2cc Insulin Syringe U-40 with 29G x 1/2'' Needles are individually packages in a container consisting of a transparent plastic bottom and a white top with green printing. 100 individual wrapped syringes per carton. The cartons are white with green printing.
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.
Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.
vitacost brand L-Citrulline Amino Acid 750 mg, 90 CAPSULES, DIETARY SUPPLEMENT, ITEM # NSI 3003310, UPC 8 35003 00331 0 --- Manufactured for Vitacost Lexington, NC 27295
vitacost brand Men's Passion Booster, 30 Capsules, PREMIUM FORMULA DIETARY SUPPLEMENT, ITEM # NSI 3004713, UPC 8 35003 00471 3, and 120 CAPSULES, ITEM # NSI 3009473, UPC 8 35003 00947 3 --- Manufactured for Vitacost Lexington, NC 27295
Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05
Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05
Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054
Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054
Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054
Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054
H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054
H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
Rotavirus Test Card LumiQuick, Santa Clara, CA 95054
Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
Legionella Test Card; LumiQuick, Santa Clara, CA 95054
H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054
Strep A Test Card; LumiQuick, Santa Clara, CA 95054
Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054
Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054
Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054
Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054
Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054
Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054
Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054
PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054
Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054
Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054
Tramadol Test Card; LumiQuick. Santa Clara, CA 95054
Tramadol Strip; LumiQuick. Santa Clara, CA 95054
Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054
Amphetamine Strip; LumiQuick. Santa Clara, CA 95054
Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054
Barbiturate Strip; LumiQuick. Santa Clara, CA 95054
Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054
Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054
Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054
Cocaine Strip; LumiQuick. Santa Clara, CA 95054
Cocaine Test Card; LumiQuick. Santa Clara, CA 95054
EDDP Strip; LumiQuick. Santa Clara, CA 95054
EDDP Test Card; LumiQuick. Santa Clara, CA 95054
MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054
MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054
Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054
Methadone Test Card; LumiQuick. Santa Clara, CA 95054
Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054
Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054
Morphine Strip (300); LumiQuick, Santa Clara, CA 95054
Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054
Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054
PCP Test (Strip); LumiQuick, Santa Clara, CA 95054
PCP Test Card; LumiQuick. Santa Clara, CA 95054
THC Strip; LumiQuick,. Santa Clara, CA 95054
THC Test Card; LumiQuick,. Santa Clara, CA 95054
Ketamine Strip; LumiQuick,. Santa Clara, CA 95054
Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054
Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054
Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054
Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054
Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054
Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054
Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054
Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054
Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054
K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054
K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054
Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054
Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054
Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054
Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054
CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.
Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1.
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 .
Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.
Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.
Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1.
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1.
Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1.
Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.
Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2.
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.
Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control Product Usage: Is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Enhanced Bali Leaf Powder, Max Kratom, Capsule, UPC Code 5410600332, 20 count pack, 5 servings per pack, Herbal Dietary Supplement.
Enhanced Maeng Da Leaf Powder, Maeng Da Kratom, capsule, UPC code 5410600330, 10 Pack, 2 Servings Per Pack, 10 grams.
All Natural, XL Kratom, Herbal Dietary Supplement, capsule, UPC code 5410600307, 4 capsules per package.
Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle.
The Other Macaroon G'nache P'nache 5.3 oz. Manufactured and Distributed by:Northern Valley Baking Co LLC, Dumont, New Jersey USA
Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
Fannie May Assorted Chocolates Rich dark & milk chocolate & pastels with an assortment of decadent fillings NET WT 14 OZ (396 g) Assorted Chocolates Nutrition Facts:***Ingredients: SUGAR, MILK CHOC LATES***CONTAINS: EGGS, MILK, SOY, TREE NUTS. WHEAT, GLUTEN***Distributed By: Fannie May Confections Brands, Inc., Chicago, IL 60160 www.fanniemay.com'' UPC 0 52745 72804 6
7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Wing Bran-Bkrs 40# 30/PAL720600, #14535 , Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72060 5, Ingredients Wheat Bran. Wingold Bran - Bakers 40#720500, Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72050 6, Ingredients What Bran.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Rantidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.
Orton Bros. Brand Zesty Lemon Cookie Buttons; 6 oz. yellow box, UPC code 20104 19100. The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14.
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
Hard Blast Pink Lemonade Net Wt. 19 oz. Developed and exclusively distributed by: TBI Labs LLC, Miami, FL 33137 www.tbilabs.com 888-253-0958 Made in USA UPC 628586182561
Juggernaut a) Crimson Punch UPC 811020906803 b) Orange UPC 811020906841 c) Raspberry Lemonade UPC 811020906858 Net Wt. 1.76 lbs. Manufactured in the USA Infinite Labs, LLC PO Box 533736 Orlando, FL 32853 1-877-455-2271
i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz
i heart keenwah Almond All Natural Quinoa Clusters. UPC 736211802347 for the 4 oz UPC 713757598200 for the 1 oz
i heart keenwah Ginger Peanut All Natural Quinoa Clusters. UPC 736211802644 for the 4 oz UPC 713757598408 for the 1 oz
i heart keenwah Cranberry Cashew All Natural Quinoa Clusters. UPC 736211802545 for the 4 oz UPC 713757598309 for the 1 oz
i heart keenwah Peanut Butter Cacao All Natural Quinoa Clusters. UPC 736211884442 - 4 oz 12 units/cs
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 automatic external defibrillator.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
Diced Dry Bean Curd. Manufactured by: E Won Trading Company, LTD. Distributed by: Win Luck Trading Co. LLC, 100 Pulaski Street, Bayonne, NJ 07002. UPC 4716670715248. 10.58 oz (300g) plastic bag.

Code Info
UPC 51000 2549 4, Expiration date JUN 16, 2015, Lid Codes JUN 16 2015 12153 CT BJ ZV 0330 through JUN 16 2015 12153 CT BJ ZV 0449
No lot code information or exp date on packaging.
UPC Code 6 26425 10092 9. Production code 347 31##, marked on a sticker on the end of the styrofoam tray.
Catalog Number: MV1/2CCINS-40; Lot Number: 20120610
Suspect date codes for Breast Pumps: P12324-91667C to P13205-30673C. Suspect adaptor date codes: 1241 to 1324.
Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].
Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005
Batch # 1080, EXP: July 2015; Batch # 1102, EXP: Septempber 2017.
Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 2017.
Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 2017.
(10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018.
(10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014.
Batch # 2089; EXP: June 2014; Batch #3031 , EXP: June 2016.
Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016.
10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015.
Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017.
Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017.
10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017.
Batch # 23109; EXP: September 2014; Batch # 08030; EXP: February 2015; Batch # 12032; EXP: February 2017; Batch # 26043; EXP: March 2018.
Batch # 27100; EXP: September 2015; Batch # 29100; EXP: October 2015; Batch # 25013; EXP: January 2018.
Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018.
Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108.
10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017.
a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014
Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542.
The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14.
a) Crimson Punch - Lot #13086 - exp date 04/01/2015 b) Orange - Lot #13085 - exp date 04/01/2015 c) Raspberry Lemonade - Lot #13087 - exp date 01/01/2015
All codes which read EXPDDMMYY (all dates)
SKU/Item Number 66838, Sold June 2009 to March 2014.

Product Quantity
13 boxes distributed domestically & 50 boxes distributed internationally to consumers
3 boxes distributed domestically & 4 boxes distributed internationally to consumers.
30 capsules: 2169 bottles; 120 capsules: 2052 bottles
Total of 5 units (2 units in the US and 3 units in Germany)
730 10 x 1mL Cartons; 367 50 x 1 mL Cartons
55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons
32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons
126 10 x 1 ml Cartons; 76 50 x 1ml Cartons
Approximately 8032 cs 4 oz 12 units/cs; 1 oz 24 units/cs
approximately 4899 cs - 4 oz 12 units/case; approximately 475 cs - 1 oz 24 units/cs
approximately 3143 cs - 4 oz 12 units/case; approximately 322 cs - 1 oz 24 units/cs
approximately 4979 cs -4 oz 12 units/cs; approximately 511 cs -1 oz 24 units/cs
approximately 1405 cs - 4 oz packages/12 per case
20 Cartons (each carton contains 12 bags)

Reason for Recall
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
A high level of Copper was discovered in the feed.
Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Product may have become spoiled due to an elevated pH caused by dilute cleaning solution in the product.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Potential for Listeria monocytogenes contamination.
Evolution Fresh is recalling Organic Sweet Green and Ginger Juice out of an abundance of caution.
The barrels on 1/2cc Insulin Syringe U-40 with 29G x 1/2'' Needles are not marked correctly. The marking on the barrel indicate that 1/2cc of U40 insulin contains 40 units of insulin instead of 20 units of insulin.
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Some of the power adapters outer casing may become loose and separate, resulting in a potential for electric shock.
The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline.
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although the two products contain the same active ingredient, methylphenidate, the Medication Guides are not identical because the two products contain different excipients.
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients.
Northern Valley Baking Company did not declare milk or soy on the allergen statement of G'nache P'nache.
Labeling; Missing label; ampoules are missing the immediate container label
Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).
Alcon LenSx received reports of unexpected downward motion of the gantry.
The product is being recalled due to an undeclared allergen of peanuts in the ingredient statement.
The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.
Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Bay State Milling Company is recalling select lot codes of bran produced in its Winona, MN mill between February 10, 2014 and March 7, 2014. The decision to voluntarily recall the product is based upon findings of metal fragments in the product.
The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures that manually filled cassettes are at the proper level.
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a ''foreign material'', identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare's high standards. The original design includes a pin that over time and years of use may stop performing as designed and may break.
Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. Although this is the standard abbreviation for natural rubber (latex), CFR 21 Part 801 Sec. 801.437 requires additional language. It is unclear whether the labelling of the product played any part in the reported incident.
Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Command Nutritionals LLC is recalling Hard Blast-Pink Lemonade and Juggernaut- Various flavors due to contaminated L-Citrulline which was received from Axel Chemicals, Brentwood, TN.
An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of i heart keenwah, quinoa clusters and soy was not declared on the product labeling.
A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.
The recall was initiated after it was discovered that the product contains unallowed dye:16255-Ponceau 4r(E124) Acid Red 18 and undeclared FD&C Yellow # 6.