Nationwide (CA, CO, CT, FL, HI, IL, IN, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI); Canada
The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.
List Number: 06J37-018; Lot Number: 440023
20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.
JaDera, 100% Natural Weight Loss Supplement, capsules,  30 count bottle
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling  RezzRX due to undeclared  hydroxylthiohomosildenafil and aminotadalafil.
Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Valeant Pharmaceuticals North America LLC DBA Orapharma Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA
Obagi Medical C-Cleansing Gel, deeply Cleans to Remove Makeup and Excess Oil, 33.8 fl. oz. (1 L), Not for Retail Sale, Distributed by OMP, Inc., Long Breach, CA 90806
Product was mislabeled as Obagi Medical Toner
Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.
Heartware HVAD Pump Implant Kit  (Heartware Ventricular Assist Device)   Product Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.
Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.
Worldwide Distribution - USA Nationwide in the states of:  AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software.  Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
251 units (148 units domestically & 103 units internationally)
RaySearch Laboratories has recalled ''RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0'' software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
MULTIX FUSION.   The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose, and could potentially crash down during an examination.
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631    B) Discount Drug Mart Non-Drowsy 24 Hour Formula  Allergy Relief and Nasal Decongestant, Loratadine, USP 10 mg/Antihistamine Pseudephrine Sulfate, USP 240 mg/Nasal Decongestant  Extended Release Tablets, 15-count box  Distributed by Drug Mart-Food Fair Medina, Ohio 44256 UPC 093351116285    C) Kroger Non-Drowsy Allergy and Congestion Loratadine and Pseudoephedrine Extended Release Tablets  Pseudoephedrine Sulfate, USP 240 mg Nasal Decongestant  Loratadine, USP 10 mg, Antihistamine 10- count box, Distributed by The Kroger Co., Cincinnati, Ohio 45202  NDC 30142-0724-69.    D) Sunmark Allergy & Congestion Lorata*dine D Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, Indoor & Outdoor Allergies, Non-Drowsy 10- count box, Distributed by Mckesson One Post Street, San Francisco, CA 94104 NDC 49348-543-01    E) Good Neighbor Pharmacy  Non-Drowsy Allergy and Congestion Relief  pseudoephedrine sulfate, USP 240 mg/nasal decongestant loratadine, USP 10 mg/antihistamine Indoor & Outdoor Allergies Extended-Release Tablets, 10- count box, Distributed by Amerisource Bergen 1300 Morris Drive, Chesterbrook, PA 19087 NDC46122-0167-52    F) H-E-B Allergy Relief - D Non-Drowsy- 24 Hour Formula Loratadine, USP 10mg/Antihistamine Pseudoephedrine Sulfate, USP 240 mg/Nasal Decogestant Indoor & Outdoor Allegies, Allergy & Congestion Extended-Release Tablets 10-count box, Distributed by H-E-B San Antonio, TX 78204    NDC 37808-0724-69    G) Rite Aid Pharmacy allergy relief & nasal decongestant loratadine USP, 10 mg, pseudoephedribe sulfate USP, 240 mg, antihistam
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV, and WI, and the countries of  Algeria, Andorra, Armenia, Argentina, Austria, Australia, Azerbaijan, Belarus, Bermuda, Bahamas, Boliva, Brazil, Canada, Chile, China, Costa Rica, Cyprus, Czechoslovakia, Germany Guatemala, Denmark, Estonia, Egypt, Finland, France, Great Britain, Georgia, Guadeloupe, Greece, Guyana, Curacao, Hungary, Israel, India, Italy, Jordan, Japan, Kuwait, Kazakhstan, Luxembourg, Latvia, Libya, Madagascar, Macedonia, Martinique, Malta, Mauritius, Mexico, Nicaragua, Nigeria, Netherlands, Norway, Oman, Peru, French Polynesia, Poland, Portugal, San Marino, Singapore, Spain, Suriname, San Salvador, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan, Wallis & Futuna Islands, Zambia.
Sengstaken Tube and Sengstaken-Blakemore Tube.  Teleflex product codes 204800, 204802, and 204803,  a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
Sterility of the product cannot be guaranteed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
US Distribution including the states of  OK, IL, NJ, and WA.
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.   Proton therapy
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
US Nationwide including Puerto Rico; Mexico, Columbia
VPRIV (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette.   For administration of blood and blood bags for use with Plum Series Infusers.
Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which were incorrectly stored in a single storage bag, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of   Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.
Stryker PenAdapt''; Rx Only, Sterile.   This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.
During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier.  Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the package of the product.
Blood products, collected from a donor who was taking the medication Propecia, were distributed.
Blood product, labeled with the incorrect anticoagulant, was distributed.
American Red Cross Blood Services Tennessee Valley Region
Blood Product, prepared from an overweight unit, was distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood Systems, Inc. DBA United Blood Services
Blood product, manufactured from an overweight whole blood unit, was distributed.
Blood product, which was collected from a donor who  traveled to a malarial endemic area, was distributed.
American National Red Cross (The) - North Central Region
Blood product, in which quality control/distribution of product did not meet specifications.
Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT.  There was no foreign/military/government distribution.
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box.  The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802.  The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
DR0800M box lot numbers 1314413, Exp. 30Jun2014, and 1301907, Exp. 31May2014; DR0802 reagent bottle lot number 1265366, exp. June 2014
A reagent contained within the product may return false negative results.
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box.  The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802.  The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014
Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.
TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell  with Cluster Holes, Porous 60mm.   Catalog number 00-6202-060-22; Hip implant component.
Three complaints were received in which it was noted intra-operatively that the shell was missing the locking ring.
Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger,  Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.
Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger,  Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
Nicorette Lozenge,  Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination.  Contains 30 Pieces/ Pallet.  OTC only.  GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland.  20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03.
Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland.  20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.
Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only.  GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108.  UPC: 0-03-0766-1480-30-2.
Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.
Fassier-Duval IM Telescopic System.  Orthopedic intramedullary rod implant.  Catalogue number FD-040(L)-SS.                                                 -Duval IM Telescopic System.
The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
Worldwide Distribution: US (nationwide) and country of Canada.
ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A,  a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
Branan Medical is recalling the ToxCup Drug Screen Cup because they may be labeled with incorrect result interpretation graphics on the ToxCup lid label.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
ZYM B Reagent (REF 70493).   The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562).  The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
FB Reagent (REF 70562).   FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
API NIH (REF 10400).   ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
API Listeria (REF 10300).   ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.
American Red Cross Blood Services Heart of America Region
Blood product, for which the entire amount of additive solution was not added during manufacturing, was distributed.
Blood products, in which quality control testing was performed, interpreted, or documented incorrectly,  were distributed.
Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
Arrow is recalling the Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet due to a labeling inconsistency. Arrow has received complaints for lot 23F14A0375 that kits are packaged with the incorrect catheter, specifically the kits contain a 40cm catheter and should contain a 50cm catheter.
US Distribution including the states of  IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number  AK-45854-CDC.
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock  correctly identifies the catheter as 8.5FR x 20CM
Blood product, collected from a donor without documentation of a body temperature, was distributed.
Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Northern California Community Blood Bank
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed
Nationwide: US:  AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
Units distributed from November 2006 through March 2014.
The footboard of Patient support for stitching can be fixed in upper position.  When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
Worldwide Distribution - US Distribution including Puerto Rico and the states of  CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.
Philips  MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).    The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others
Software Versions:  MDC PACS R2.2; R2.3   IntelliSpace PACS DCX R3.1
Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
Tikosyn  (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60
Presence of Foriegn Tablets/Capsules: A single Tikosyn (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn (dofetilide) 500 mcg (0.5 mg).
Creative Snacks Co. Dried Apricots (10.5 oz Rigid Plastic Cup, and 7 oz Clear Plastic Bag), Distributed by: Creative Snacks, Co., Greensboro, NC 27409
276 cs (3312 units)  10.5 oz Dried Apricot (Cups) & 44 cs (264 units)  7 oz Dried Apricot (Bags)
Product contains undeclared allergen, Sulfites
Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.
Product Code: 0520197-2, Lot number: 02H1001071; Product Code: 29-727, Lot numbers: 02M1101954, 02C1201003, and 02C1201646; Product Code: 29-7270M4, Lot number: 02D1100604; Product Code: 29-7281M4, Lot number: 02M1002679; Product Code: E29-5553M4, Lot number: 02B1300245; Product Code: E29-7270M4, Lot number: 02J1001576; Product Code: E29-7272M4, Lot number: 02D1003015; Product Code: E29-727A, Lot number: 02F1101062; Product Code: EP4013P, Lot number: 02L0800898; Product Code: EP4110N, Lot number: 02H0900483; Product Code: X-2235, Lot numbers: 02E1102068, 02F1101041, 02F1201500, and 02G1201230; Product Code: X29-7271M2, Lot number: 02K1100784; Product Code: X-5667M8 and Product Code: X-6730M5, Lot number: 02G1300492.
The products are being recalled because they did not meet minimum diameter requirements.
On-Board Imager -  Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01'' elbow motors.     Product Usage:  The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI.   OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
Worldwide Distribution-US (nationwide) except the states of ND and RI, including DC, GU, PR, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA,INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA.
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
GE Healthcare has recently become aware of a potential safety issue with gradient coil electromechanical connections associated with GE MR Products.   Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the Endbell. This overheating has occurred only while units were being serviced by GE service engineers during repeated evaluation scanning. However, the issue could also occur in Clinical mode.
US only. Spourts Farmers Market stores in Arizona, California, Colorado, Kansas, New Mexico, Nevada, Oklahoma, Texas, and Utah.
Sprouts Farmers Market Organic Whole Black Peppercorns, 2.12oz., UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246.   Packaged in glass jars with plastic lid.    Product labeling reads in part:''SPROUTS FARMERS MARKET organic Black Peppercorns ***NET WT 2.12 OZ (60g)***Manufactured Exclusively For Sprouts Farmers Market Phoenix, Arizona 85028***www.sprouts.com***SP00056***8 74875 00425 4***''.
Sprouts Farmers Market, Inc.  is recalling Organic Whole Black Peppercorns, Lot 3287 after FDA test results revealed the presence of Salmonella and Lot 3246 as precaution because it has the potential to be contaminated with Salmonella.
Recalled product was shipped nationwide and to Canada and Indonesia. The firm has no government or military consignees.
1) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 11.3 Kg 25 LB. Packaged in corrugated cardboard boxes. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-82603-9.; 2) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 453 g 16 OZ. Packaged in foil pouches. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-02603-3;  3) Frontier Natural Products Co-op, Black Peppercorns Whole. Net WT. 2.12 OZ (60 g). Packaged in glass jars. Distributed by Frontier Natural Products Co-op, Norway, IA. UPC 0-89836-18435-1;   4) Simply Organic, black peppercorns. NET WT. 2.65 OZ. (75g). Packaged in glass jars. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-18524-2.;  5) Simply Organic, Adjustable Grinder Cap, daily grind. NET WT. 2.65 OZ. (75g). Packaged in glass jars with a grinder cap. Distributed by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.;  6) Simply Organic, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19210-3.;  7) Simply Organic, Adjustable Grinder, Broyeur Rglable, black peppercorns, poivre noir en grains. NET WT. 2.65 OZ. POID NET 75g. Packaged in glass jars. Manufactured by Frontier Natural Products, Norway, IA. UPC 0-89836-19218-9.;  8) 365, Black Peppercorns, NET WT 1.87 OZ (53g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44497-6;  9) 365, Black Peppercorns, NET WT 2.12 OZ (60g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44563-8.;  10) 365, Black Peppercorns, NET WT 8.08 OZ (229g). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-44511-9.;  11) 365, Organic Black Peppercorns Grains de Poivre noir biologique, 60g (2.12 OZ). Packaged in glass jars. Distributed by Whole Foods Market, Austin Texas. UPC 0-99482-73914-0;  12) Nature's Pla
Testing of organic whole black peppercorns revealed the presence of Salmonella
USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software.  Used for ultrasound examinations of intravascular pathology.
Model Numbers: H749ILAB120CART0  H749ILAB120INS0  H749ILAB120N2710  Serial numbers:  4219, 4900, 5701, 5827  7516, 7517, 7607  8407, 8434.  the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software.
Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.
New Jersey, New York, Rhode Island, and Maryland
Lisy Sweet Basil Albahaca Net WT/Cont. Neto 6oz. (171g)  Item 1132 www.lisycorp.com Packed on a clear plastic container with a UPC # 0 96786 30032 8
FDA sample collected was found to be positive for salmonella spp.
Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags.
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado based natural grocery chain, is recalling multiple lots of Natural Grocers brand Organic Black Peppercorns as the product has the potential to be contaminated with Salmonella.
USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
Firm is not registered as a drug manufacturer.
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0   Product Usage:  A topical gel that increases sexual excitement and pleasure.
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8   Product Usage:  Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens sexual excitement and pleasure.
Distribution was made to CA, CO, FL, GA, IA, IL, KS, KY, MA, MI, MO, NE, NJ, NY, OH, OK, OR, PA, SD, TX, WA and WI.
Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873    American Pop Corn Company, Sioux City, IA.
The product has the potential to be contaminated with stainless steel metal fragments.
Jolly Time Microwave popcorn, Extra Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton - UPC 028190008477, on the 12 count case - UPC 10028190008474 and 48 ct shipper with UPC 128190488474    American Pop Corn Company, Sioux City, IA.
Jolly Time Microwave popcorn, Homemade Classic Stovetop Flavor, 3/3-oz bags/carton.  The cartons are packaged 12-cartons/case.  Individual carton - UPC 028190007807, on the 12-ct case - UPC 10028190007804, 48-ct shipper UPC 128190487804  American Pop Corn Company, Sioux City, IA
Best By code of 04/01/15 (Julian date) 4091
Cinnamon Cookie Manjoo, 200g Net Weight.   Packaged in clear plastic bag, 10 per bag.  Product package labeled in part:''***Cinnamon Cookie (Manjoo)*** Net Wt. 200g, 7.1oz***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039219***.
Production batch: 1/1/2013-03/13/2014. No codes on finished packaging.
CJ Foodville USA, Inc. is recalling its chocolate madeline, madeline, and cinnamon cookie manjoo because the product labels do not declare the food allergen wheat.
Madeline, 80g Net Weight.   Packaged in clear plastic bag, 4 per bag.  Product package labeled in part:''AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***.
Production batch: 1/1/2013-03/13/2014    No codes on finished package.
Chocolate Madeline, 80g Net Weight.   Packaged in clear plastic bag, 4 per bag.  Product package labeled in part:''AUTHENIC BAKERY TOUS Les JOURS***Madeline*** Net Wt. 80g, 2.8oz ***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039249***.
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B)  Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0  F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9;
Subpotent Drug: Phenylephrine component is subpotent.
Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Liechtenstein, Malaysia, Mauritius, Montenegro, Namibia, Nepal, Nigeria, Norway, Palestinian Ter, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Turkmenistan, U.A.E., United Kingdom.
Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02.  ultrasound imaging system.
Model numbers: 1065844  ACUSON X700 Ultrasound System  10658846 - ACUSON X700 Ultrasound System (Russia)  10658845 - ACUSON X700 Ultrasound System (Korea)
When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.
Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.
ev3 EverCross 0.035'' OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm,   REF:  AB35W06120135.  and ev3 EverCross 0.035'' OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm  REF:  AB35W06040080.  Peripheral Dilatation Catheter
Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error.  There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
Worldwide Distribution:  USA Nationwide and China. No military/govt/VA consignees.
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035'' (0.89mm), 260 cm (102'').
Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035'' 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035'' 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.
Merit Laureate 0.035'' (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102'').
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035'' 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035'' 260 cm Guide Wire, catalog number   LWSTDA35260EX, lot number K556402 (186 units), which has an angled tip, standard shaft and Chinese unit labeling.
Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.