Roche Brothers Berry Nutty Mix trail mix packed in 9 oz. and 20 oz. clear plastic containers
Ava's Berry Nutty Mix trail mix packed in 20 oz. clear plastic containers.
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.1 mg (100 mcg) packaged in 180-tablet and 1,000 tablet bottles. Manufactured for Pala-tech Laboratories Inc.
11,885 180-count bottles, 2343 1000-count bottles.
An FDA inspection revealed a failure to follow current good manufacturing practices in the manufacturing the various finished pharmaceuticals containing the active ingredient levothyroxine used in the treatment of hypothyroidism in dogs and horses.
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.2 mg (200 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
17,036 180-count bottles, 3,664 1000-count bottles
(1) Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.3 mg (300 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.; (2) Caninthrox (Levothyroxine Sodium, USP) 0.3 mg (300 mcg) Manufactured for BET Laboratories, Lexington, KY;
11,870 180-count bottles, 2,290 1000-count bottles
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.4 mg (400 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
14,356 180-count bottles, 2,437 1000-count bottles
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.5 mg (500 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
16,125 180-count bottles, 2,752 1000-count bottles
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.6 mg (600 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
22,069 180-count bottles, 3,838 1000-count bottles
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.7 mg (700 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
12,693 180-count bottles, 1,814 1000-count bottles
(1) Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.8 mg (800 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.; (2) Caninthrox (Levothyroxine Sodium, USP) 0.8 mg (800 mcg) packaged in 1,000-tablet bottles. Manufactured for BET Laboratories, Lexington, KY;
30,720 180-count bottles, 5,857 1000-count bottles
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 0.9 mg (900 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
8,369 180-count bottles, 1,048 1000-count bottles
Pala-Tech Canine Thyroid Chewable Tablets (Levothyroxine Sodium, USP) 1.0 mg (1,000 mcg) packaged in 180-tablet and 1,000-tablet bottles. Manufactured for Pala-tech Laboratories Inc.
12,621 180-count bottles, 2,248 1000-count bottles
(1) Pala-Tech Equine Thyroid Supplement 0.22% Levothyroxine Sodium, USP (1.0 gram per 454 grams of product) powder packaged in 454 gram (1 pound) and 4,540 gram (10 pound) containers. Manufactured for Pala-tech Laboratories Inc. (2) Equithrox Equine Thyroid Supplement 0.22% Levothyroxine Sodium, USP (1.0 gram per 454 grams of product) powder packaged in 4,540 gram (10 pound) containers. Manufactured for BET Labs, Lexington, KY.
28,027 1 lb containers,  2,402 10 lb containers
Product was distributed nationwide, as well as to Puerto Rico and The Virgin Islands.  Foreign distribution was made to Canada.  There was also military distribution.
Frontier Natural Products Co-Op Garlic Powder, Certified Organic, Non-Irradiated with responsible firm name Frontier Norway, IA packaged in the following configurations:   (1) Foil packet labeled Powdered Garlic Allium sativum, Net 453 g 16 oz. UPC code 0 89836 00352 2;    (2)  Glass bottle with green plastic cap labeled Garlic Powder, Net Wt. 2.33 oz (66 g) UPC code 0 89836 18351 4; and    (3) Poly-lined plastic bag inside of a cardboard box labeled Powdered Garlic Allium sativum, Net 11.3 Kg 25 LB UPC code 0 89836 80352 8.
(1) Powdered Garlic: lots 4156 and 4171 use by Jun 2017; lot 4238 use by Aug 2017; lot 4297 use by Oct 2017; lot 4325 use by Nov 2017; lot 4342 use by Dec 2017; lots 5033 and 5041 use by Feb 2018;    (2) Garlic powder:  lot 4183 use by Jul 2017; lot 4224 use by Aug 2017; lot 4268 use by Sep 2017; lot 4315 use by Nov 2017; lot 4349 use by Dec 2017; and lot 5023 use by Jan 2017; and    (3) Bulk Powdered Garlic:  lot 4171 use by Jun 2017; lot 4238 use by Aug 2017; lot 4297 use by Oct 2017; lot 4325 use by Nov 2017; lot 4342 use by Dec 2017; and lot 5033 use by Feb 2017.
13,512 packets; 17654 bottles; and 148 boxes.
Product may be contaminated with Salmonella.
Frontier Natural Products Co-Op Fiesta Black Bean Mix Certified Organic packaged in a foil packets, Net 453 g 16 oz, UPC 0 89836 02761 0.  The responsible name on the package is Frontier Norway, IA.
lot  4160 use by Jun 2017; lot  4226 use by Aug 2017;  lot  4307 use by Nov 2017;  lot  4364 use by Dec 2017; and  lot 5005 use by Jan 2018.
Frontier Natural Products Co-Op Refried Pinto Beans Mix Certified Organic packaged in a foil packet, Net 453 g 16 oz, UPC 0 89836 02762 7.  The responsible name on the package is Frontier Norway, IA.
lot 4240 use by Aug 2017; lot 4322 use by Nov 2017; and  lot 4345 use by Dec 2017.
Frontier Natural Products Co-Op Low Sodium Broth Powder Vegetable Flavored Certified Organic packaged in a foil packet, Net 453 g 16 oz, UPC 0 89836 02780 1.  The responsible name on the package is Frontier Norway, IA.
lot 4157 use by Jun 2016; lot 4198 use by Jul 2016;   lot 4240 use by Aug 2016;  lot 4281 use by Oct 2016;   lot 4328 use by Nov 2016; and  lot 5002 use by Jan 2017.
Frontier Natural Products Co-Op Vegetarian Broth Powder No - Chicken Certified Organic.  The responsible name on the package is Frontier Norway, IA.  The product is packaged in the following configurations:   (1) Foil packet, Net 453 g 16 oz, UPC 0 89836 02869 3; and     (2) Poly-lined plastic bag inside of a cardboard box, Net 11.3 Kg 25 LB, UPC 0 89836 82869 9.
Foil packets:  lot 4157 use by Jan 2016; lot 4178 use by Jan 2016;  lot 4197 use by Feb 2016;  lot 4238 use by Mar 2016;  lot 4239 use by Mar 2016;  lot 4267 use by Apr 2016;  lot 4280 use by May 2016;  lot 4336 use by Jun 2016;  lot 4353 use by Jul 2016;  lot 5007 use by Jun 2017;  lot 5035 use by Jul 2017; and  lot 5036 use by Jul 2017.    Plastic poly-lined bag in cardboard box:  lot 4178 use by Jan 2016;  lot 4336 use by Jun 2016;  lot 5007 use by Jun 2017; and   lot 5036 use by Jul 2017.
Frontier Natural Products Co-Op Onion Soup & Dip Mix Certified Organic packaged in a foil packet, Net 453 g 16 oz, UPC 0 89836 02918 8.  The responsible name on the package is Frontier Norway, IA.
lot 4143 use by Nov 2016; lot 4246 use by Apr 2016;   lot 4258 use by Apr 2016;  lot 4279 use by May 2016;  lot 4290 use by May 2016;  lot 4318 use by Jun 2016;  lot 4335 use by Jul 2016;  lot 4349 use by Jul 2016; and   lot 5036 use by Jul 2017.
Frontier Natural Products Co-Op Organic Mama Garlic packaged in a cardboard canister with paper label Net  Wt. 5 oz (141 g), UPC 0 89836 18506 8.  The responsible name on the package is Frontier Norway, IA.
Ranch Dip / Dressing Mix Certified Organic packaged the following containers under multiple labels:  Frontier Natural Products Co-Op foil packet Net  453 g 16 oz, UPC 0 89836 02926 3; Simply Organic foil-lined paper packet Net Wt. 1.00 oz (28 g), UPC 0 89836 18833 5; and Simply Organic foil-lined paper packet Net Wt. 1.50 oz (43 g)  UPC 0 89836 18840 3 .  The Simply Organic 1.50 oz (43 g) product is also labeled in French with UPC 0 89836 18877 9 and a net weight of 42 g.  The responsible name on the package is Frontier Natural Products Co-Op Norway, IA.
16 oz.:  lot 4199 use by Jul 2017; lot 4247 use by Sep 2017; lot 4317 use by Nov 2017; lot 4363 use by Dec 2017; lot 5022 use by Jan 2018; and lot 5055 use by Feb 2018.   1.5 oz.:  lot 4194 use by Jul 2016; lot 4195 use by Jul 2016; lot 4226 use by Aug 2016; lot 4274 use by Oct 2016; lot 4315 use by Nov 2016; lot 4356 use by Dec 2016; lot 4360 use by Dec 2016; and lot 5028 use by Jan 2017.    1.0 oz.:  lot 4147 use by May 2016; lot 4195 use by Jul 2016; lot 4225 use by Aug 2016; lot 4274 use by Oct 2016; lot 4315 use by Nov 2016; lot 4356 use by Dec 2016; lot 5027 use by Jan 2017; and lot 5028 use by Jan 2017.
Frontier Natural Products Co-Op Pepper Fusion Black Peppercorns with Garlic Certified Organic packaged in a glass bottle Net Wt. 1.76 OZ. (50 g),  UPC 0 89836 19502 9. The responsible name on the package is Frontier Norway, IA.
lot 4321 use by Nov 2017; and  lot 4356 use by Dec 2017
Simply Organic Italian Herb Spaghetti Sauce Mix Certified Organic packaged in foil lined paper packet Net Wt. 1.31 OZ. (37 g), UPC 0 89836 15710 2.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4199 use by Jul 2016; lot 4245 use by Sep 2016; and   lot 4287 use by Oct 2016.
Simply Organic Chipotle Black Bean Dip Mix Certified Organic packaged in foil lined paper packet Net Wt. 1.13 OZ. (32 g), UPC 0 89836 15714 0.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4262 use by Sep 2016; and  lot 4344 use by Dec 2016.
Simply Organic Fish Taco Seasoning Certified Organic packaged in foil lined paper packet Net Wt. 1.13 OZ. (32 g), UPC 0 89836 18534 1.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4245 use by Sep 2016;  lot 4300 use by Oct 2016;   lot 4330 use by Nov 2016; and   lot 5012 use by Jan 2017.
Simply Organic Roasted Garlic Spaghetti Sauce Mix Certified Organic packaged in foil lined paper packet Net Wt. 1.13 OZ. (32 g), UPC 0 89836 18543 3.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4245 use by Sep 2016; and   lot 4286 use by Oct 2016.
Simply Organic Classic Caesar Dressing Certified Organic packaged in foil lined paper packet Net Wt. 1.25 OZ. (35 g), UPC 0 89836 18836 6.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4149 use by May 2016; lot 4196 use by Jul 2016; and   lot 4232 use by Aug 2016.
Simply Organic Alfredo Sauce Mix Certified Organic packaged in foil lined paper packet Net Wt. 1.48 OZ. (41 g), UPC 0 89836 18544 0.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4182 use by Jul 2016; lot 4223 use by Aug 2016;  lot 4224 use by Aug 2016;  lot 4272 use by Sep 2016;  lot 4353 use by Dec 2016; and  lot 5027 use by Jan 2017.
Simply Organic Enchilada Sauce Seasoning, Certified Organic, packaged in foil lined paper packet Net Wt. 1.41 OZ. (40 g), UPC 0 89836 18744 4.  The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4247 use by Sep 2016; lot 4290 use by Oct 2016;  lot 4336 use by Dec 2016;  lot 5012 use by Jan 2017;  lot 5033 use by Feb 2017.
Simply Organic Fajita Seasoning Certified Organic packaged in foil lined paper packet Net Wt. 1.0 OZ. (28 g), UPC 0 89836 18535 8.  The product is also marketed under a French/English label Net Wt. 28 g, UPC 0 89836 20002 0. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4118 use by Apr 2016;  lot 4246 use by Sep 2016;  lot 4287 use by Oct 2016;  lot 4332 use by Nov 2016;  lot 5007 use by Jan 2017;  lot 5008 use by Jan 2017; and  lot 5030 use by Jan 2017.
Simply Organic Vegetarian Chili Seasoning Certified Organic packaged in foil lined paper packet Net Wt. 1.0 OZ. (28 g), UPC 0 89836 18536 5.  The product is also marketed under a French/English label Net Wt. 28 g, UPC 0 89836 18870 0. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4208 use by Jul 2016; lot 4259 use by Sep 2016;  lot 4282 use by Oct 2016;  lot 4311 use by Nov 2016;  lot 5015 use by Jan 2017; and  lot 5047 use by Feb 2017.
Simply Organic Spicy Chili Seasoning Certified Organic packaged in foil lined paper packet Net Wt. 1.0 OZ. (28 g), UPC 0 89836 18537 2  The product is also marketed under a French/English label Net Wt. 28 g, UPC 0 89836 18871 7. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4212 use by Jul 2016; lot 4260 use by Sep 2016;  lot 4272 use by Sep 2016;  lot 4282 use by Oct 2016;  lot 4311 use by Nov 2016;  lot 4343 use by Dec 2016;   lot 5016 use by Jan 2017; and   lot 5050 use by Feb 2017
Simply Organic Sweet Basil Pesto Sauce Mix Certified Organic packaged in foil lined paper packet Net Wt. 0.53 OZ. (15 g), UPC 0 89836 18542 6.  The product is also marketed under a French/English label Net Wt. 15 g, UPC 0 89836 20004 4. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4196 use by Jul 2016; lot 4238 use by Aug 2016;  lot 4280 use by Oct 2016;  lot 4330 use by Nov 2016;  lot 4364 use by Dec 2016; and  lot 5037 use by Feb 2017.
Simply Organic French Onion Dip Mix Certified Organic packaged in foil lined paper packet Net Wt. 1.10 OZ. (31 g), UPC 0 89836 18841 0.  The product is also marketed under a French/English label Net Wt. 31 g, UPC 0 89836 18878 6. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4157 use by Jun 2016; lot 4197 use by Jul 2016;  lot 4258 use by Sep 2016;  lot 4281 use by Oct 2016;  lot 4325 use by Nov 2016;  lot 4364 use by Dec 2016; and  lot 5040 use by Feb 2017.
Simply Organic Guacamole Dip Mix Certified Organic packaged in foil lined paper packet Net Wt. 0.80 OZ. (22 g), UPC 0 89836 18842 7.  The product is also marketed under a French/English label Net Wt. 22 g, UPC 0 89836 18879 3. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4148 use by May 2016; lot 4176 use by Jun 2016;  lot 4195 use by Jul 2016;  lot 4254 use by Sep 2016;  lot 4255 use by Sep 2016;  lot 4302 use by Oct 2016;  lot 4318 use by Nov 2016;  lot 4363 use by Dec 2016;  lot 5029 use by Jan 2017; and  lot 5030 use by Jan 2017.
Simply Organic Creamy Dill Dip Mix Certified Organic packaged in foil lined paper packet Net Wt. 0.70 OZ. (20 g), UPC 0 89836 18843 4.  The product is also marketed under a French/English label Net Wt. 24 g, UPC 0 89836 18880 9. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4156 use by Jun 2016; lot 4197 use by Jul 2016;  lot 4237 use by Aug 2016;  lot 4279 use by Oct 2016;  lot 4323 use by Nov 2016;  lot 4324 use by Nov 2016;  lot 4365 use by Dec 2016  lot 5009 use by Jan 2017; and  lot 5035 use by Feb 2017.
Simply Organic Vegetarian Brown Gravy Mix Certified Organic packaged in foil lined paper packet Net Wt. 1.0 OZ. (28 g), UPC 0 89836 18956 1.  The product is also marketed under a French/English label Net Wt. 28 g, UPC 0 89836 20007 5. The responsible name on the package is Frontier Natural Products Co-op Norway, IA.
lot 4230 use by Aug 2016; lot 4268 use by Sep 2016;  lot 4310 use by Nov 2016;  lot 4351 use by Dec 2016; and   lot 5026 use by Jan 2017.
Whole Foods Market Organic Muchi Curry Seasoning packaged in a glass bottle, Net Wt 2.08 OZ (59 g), UPC 0 99482 44577 5. The responsible firm name on the label is Whole Foods Market, Austin, TX.
Apricot Filled Cookie OTC Sell By: (all dates up to) 3/23/2015  Net WT. 1 OZ  Contains:Egg, Wheat, Soy  ;   Cookies affected are only sold direct from bakery counter and packaged at time per customer request and packed either in clam shell plastic or wax paper.  ;   Net Weight on label may differ depending on number of cookies a customer requested. Net Weights listed above are for 1 cookie.
On 3/20/2015, it was discovered that the labels for Apricot Filled Cookie, served over the counter at retail Eagle and affiliate stores, did not declare the milk allergen. Milk was not included on the labels which state ''contains: egg, wheat, soy.''
Raisin Filled Cookie OTC Sell By: (all dates up to) 3/23/2015  Net WT. 1 OZ  Contains:Egg, Wheat, Soy  ;   OTC Raisin Filled Cookie  Sell By: (all dates up to) 3/23/2015  Net WT 2 OZ  Contains: Egg, Wheat Soy  ;   Cookies affected are only sold direct from bakery counter and packaged at time per customer request and packed either in clam shell plastic or wax paper.  ;   Net Weight on label may differ depending on number of cookies a customer requested. Net Weights listed above are for 1 cookie.
On 3/20/2015, it was discovered that the labels for Raisin Filled Cookie, served over the counter at retail Eagle and affiliate stores, did not declare the milk allergen. Milk was not included on the labels which state ''contains: egg, wheat, soy.''
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
5  UPDATE 4-20-2015 to include 10 additional devices
Smiths Medical has become aware of an issue with specific serial numbers of BCI Advisor Vital Signs Monitors (Advisors). The Auxiliary Serial Input/ Output Modes  on the Advisor do not function as expected, resulting in data formatting issues or  incorrect data being transmitted in or out of the serial port into a data collection system.  Smiths Medical received no complaints related to this issue.
Nationwide and to Canada, Japan, Philippines and United Kingdom.
Amy's Vegetable Lasagna, 9.5 oz (269 g) 12 boxes per case. UPC 0 42272 00032 6 - US Distribution:  UPC 0-42272-90032-9 - Canadian distribution    Vegetable Lasagna 8 pack - 9.5 oz, (269g)  UPC: 0-42272-00032-6 - US distribution    Family Size, 28 oz. (794 g), 8 boxes per case  UPC 0-42272-00965-7 - US distribution  Club size, 57 oz.  3.6 lbs, 1.6 kg, 6 x 9.5 oz, per case  UPC: 0-42272-00201-6    Amy's Kitchen, Petaluma, CA 94953
Item number 000032; US distribution: Lot codes: 30-A215, 30-A305, 30-B115, 30-C045 -  Item number 000032F - Canadian Distribtution  Lot code: 30-A215,   I    Family size item number 000965,  Lot code: 30-C045.    Item number 000201 - Club Size:  Lot code: 30-A205    Item number 000933 - 8 pack  Lot code: 30-A305
18101 cases (12 boxes per Case ) US: 152 cases International.
Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
Amy's Tofu Vegetable Lasagna, 9.5 oz (269 g) 12 boxes per case. UPC 0-42272-00033-3, US distribution only    Amy's Kitchen, Petaluma, CA
Amy's Garden Vegetable Lasagna, 10.30 oz (291 g) 12 boxes per case. UPC: 0-42272-00041-8, US distribution only      Amy's Kitchen, Petaluma, CA
Amy's Tofu Scramble, 9.0 oz (255 g) 12 boxes per case. UPC: 0-42272-00054-8, US distribution only    Amy Kitchen, Petaluma, CA
1822 ( 12 boxes per case) US; 276 cases international
Amy's Enchilada Verde Whole Meal, Spinach and Cheese 10.0 oz (284 g) 12 boxes per case. UPC: 0-42272-00085-2, US distribution only  8 pack, UPC: 0-42272-00085-2 - US Distribution    Amy Kitchen, Petaluma, CA
Item number 000085; Lot code: 10-A305    Item number 000940 - 8 pack:  Lot code: 10-A305.
Amy's Spinach Pizza 14.0 oz (397 g) 8 boxes per case. UPC: 0-42272-00102-6, US distribution only    Amy Kitchen, Petaluma, CA
Amy's Brown Rice & Vegetables Bowl, 10.0 oz (284 g) 12 boxes per case. UPC: 0-42272-00161-3 , US distribution only    Amy Kitchen, Petaluma, CA
Amy's Stuffed Pasta Shells Bowl, 10.0 oz (284 g) 12 boxes per case. UPC: 0-42272-00178-1, US distribution only    Amy Kitchen, Petaluma, CA
Amy's Gluten Free Tofu Scramble Breakfast Wraps, 5.5 oz 156 g) 12 boxes per case. UPC: 0-42272-00807-0, US distribution only;  UPC : 0-42272-90807-3 - Canadian distribution    Amy Kitchen, Petaluma, CA
Item number 000807; US distribution Lot codes: 30-A265, 30-B025;    Item number 00807F- Canadian distribution;  Lot code  30-B-025.
102 cases (12 boxes per case) US, 276 International
Amy's Vegetable Lasagna, Light in Sodium, 9.5 oz (269 g) 12 boxes per case. UPC: 0-42272-00240-5, US distribution only;  UPC : 0-42272-90807-3 - Canadian distribution    Amy Kitchen, Petaluma, CA
Item number 000240; US distribution Lot code: 30-C145  Item number 00807F- Canadian distribution;  Lot code  30-B-025.
Amy's Brown Rice & Vegetables Bowl, Light in Sodium, 9.5 oz (269 g) 12 boxes per case. UPC: 0-42272-00240-5, US distribution only;  UPC : 0-42272-90807-3 - Canadian distribution    Amy Kitchen, Petaluma, CA
Item number 000243; US distribution Lot codes: 30-A195, 30-C035
Amy's Gluten Free Dairy Free Vegetable Lasagna, 9.0 oz (255 g) 12 boxes per case. UPC: 0-42272-00814-8 US distribution only;  UPC: 0-42272-90814-1, Canadian distribution  UPC : 0-42272-90807-3 - Canadian distribution    Amy Kitchen, Petaluma, CA
Item number 000814; US distribution Lot codes: 30-B045;    Item Number 000814F - Canadian distribution:  Lot Code: 30-B045.
2851 cases  - 12 boxes per case - US; .698 cases international
Amy's Gluten Free Vegetable Lasagna, 4.7 oz. 6 boxes per case.     Amy Kitchen, Petaluma, CA
Item number 000856 Lot codes: 30-B095;    Item Number 000814F - Canadian distribution:  Lot Code: 30-B045.
Platelet product, for which unit labeling contained incorrect product information, was distributed.
Blood product, which was positive for K antigen, but was labeled as negative for K antigen, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was distributed to Schnuck's retail stores in MO, IA, IL, IN, and WI.  There was no foreign, military, or government distribution.
Pasta salad sold under the brand name CHEF'S EXPRESS CALIFORNIA PASTA SALAD, UPC 2 10612 30070 6.  Product is sold by weight through firm's Deli / Chef's Express department in plastic containers.  Variable weight item.  The responsible name on the label is Schnucks St. Louis, MO.
Sell dates:  April 2 - April 14, 2015. Firm does not indicate shelf-life on dispensed product.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Guayaki Brand Yerba Mate - Revel Berry; 16 oz aluminum can, Best By 12SEP16.  UPC 6 32432 73777 5    Guayaki Yerba Mate is a high energy infusion made from the leaves of the celebrated South American mate tree.    Guayaki S.R. P.  Sebastopol, CA 95472  Certified Organic by CCOF  Certified Fair Trade by IMO
26641 cases total shipped. (12 x 16 oz cans per case)
Consumer complaints received of fermented, slimy, carbonated or moldy product in on lot of Guayaki Brand Yerba Mate Revel Berry.
Blood Centers of the Pacific - Irwin Center
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, in which quality control and/or distribution of product  did not meet specifications, was distributed.
Blood product, which was not labeled with the correct  information, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest.   Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-W550, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Alll devices currently in use by consignees.
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Blood product, for which an associated plasma collection bag had a defect which may have led to sterility being compromised, was distributed.
Blood product,  in which labeling/labels applied to blood unit or product incorrect or missing information, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Worldwide Distribution - US Nationwide  and the countries of  Australia, and Canada.
The Alcon Custom Pak.   The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.
Distributed in New York, Oregon, and Pennsylvania
Salted Caramel Premium Puffed Corn, Cosmo Creations brand, Nitrogen filled, 3-layer laminate packaging, Net weight 14 oz., UPC 8 51710 00141 8.
Cosmos Creations-Salted Caramel Premium Puffed Corn, 14 oz., is recalled because the nutrition facts panel declared 0 (zero) gram sugar while it should have been 13 grams sugar per serving.
Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75.  Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
The product failed to meet the internal established statistical test requirement for heparin activity.
Red Blood Cells (Apheresis) Leukocytes Reduced
W037714032398 (double collection); W037714032968 (double collection)
Blood products, for which the donors gave history which warranted deferral or follow up and were not deferred or follow up questions were not asked, were distributed.
US Distribution in states of:OH, PA, AL, IL, TN, and CT.
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806   Usage: Flush syringe.
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Kroger Raw #4 Macadamia Nut, Dist. by the Kroger Company Cincinnati, Ohio 2 04192 50867 6
The firm was notified by the FDA of positive test results of Salmonella in their Raw Macadamia Nuts.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
Coconut Water with Pineapple, 12 bottles/case, 12 oz (355 mL)
Creative Food Concepts, Inc. dba Invo Coconut Water is recalling Coconut Water with Pineapple and Coconut Water with Thai Lime because they have no process on file and they lack a 5 log reduction process.
Coconut Water with Thai Lime, 12 bottles/case, 12 oz (355 mL)
Nationwide Distribution including AL, AZ, CA,  CA,  CO,  FL, IN,  MI,  NJ,  NY,  OH, OR, PA, TX,  VA, and WI.
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use, and has initiated a voluntary recall.
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.
A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
Failed Dissolution Specifications: Low out of specification dissolution results.
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only.  Manufactured by: FRESENIUS KABI Uppsala, Sweden.  Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Internationally to the countries of China and Norway.
Brilliance iCT Computed Tomography X-ray system
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Worldwide Distribution - US (nationwide) and Internationally to Canada, Brazil, Mexico, Bahamas, Nicaragua, Singapore, China, Japan, Malaysia, Taiwan, Thailand, Korea, Spain, Belgium, Switzerland, India, Germany, England, Italy, Saudi Arabia, Lebanon, Libya, United Arab Emirates, Algeria, France, United Kingdom, Canary Islands, Iraq, Jordan, Lithuania, Morocco, Macedonia, Malta, Mauritius, Serbia, Russian Federation, and Yemen.
Cortical Screw for M/DN Intramedullary Fixation.  Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
All lots. Part numbers:  00-2253-020-45   INTERLOCKING IM SCREW 4.5MM DIA X 20MM  00-2253-022-45   INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM  00-2253-025-45   INTERLOCKING IM SCREW 4.5MM DIA X 25MM  00-2253-027-45   M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw  00-2253-030-45  INTERLOCKING IM SCREW 4.5MM DIA X 30MM  00-2253-032-45   INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM  00-2253-035-45  INTERLOCKING IM SCREW 4.5MM DIA X 35MM  00-2253-037-45  INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM  00-2253-040-45  INTERLOCKING IM SCREW 4.5MM DIA X 40MM  00-2253-042-45   INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM  00-2253-045-45   INTERLOCKING IM SCREW 4.5MM DIA X 45MM  00-2253-047-45   INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM  00-2253-050-45   INTERLOCKING IM SCREW 4.5MM DIA X 50MM  00-2253-052-45   INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM  00-2253-055-45  INTERLOCKING IM SCREW 4.5MM DIA X 55MM  00-2253-057-45  INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM  00-2253-060-45   INTERLOCKING IM SCREW 4.5MM DIA X 60MM  00-2253-062-45  INTERLOCKING IM SCREW 4.5MM DIA X 62.5MM  00-2253-065-45  INTERLOCKING IM SCREW 4.5MM DIA X 65MM  00-2253-067-45   INTERLOCKING IM SCREW 4.5MM DIA X 67.5MM  00-2253-070-45  INTERLOCKING IM SCREW 4.5MM DIA X 70MM  00-2253-072-45   INTERLOCKING IM SCREW 4.5MM DIA X 72.5MM  00-2253-075-45   INTERLOCKING IM SCREW 4.5MM DIA X 75MM  00-2253-077-45   INTERLOCKING IM SCREW 4.5MM DIA X 77.5MM  00-2253-080-45  INTERLOCKING IM SCREW 4.5MM DIA X 80MM  00-2253-082-45  INTERLOCKING IM SCREW 4.5MM DIA X 82.5MM  00-2253-085-45   INTERLOCKING IM SCREW 4.5MM DIA X 85MM  00-2253-087-45   INTERLOCKING IM SCREW 4.5MM DIA X 87.5MM  00-2253-090-45   INTERLOCKING IM SCREW 4.5MM DIA X 90MM
The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system.  This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
PRI Femoral Impactor Block Orthopedic Manual Surgical Instrument
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Worldwide Distribution.  US naionwide including Puerto Rico, Barbados and Mexico.
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
Recovery for assayed controls are out of assigned ranges.  A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed.  Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.
Worldwide Distribution - US (nationwide) and Canada.
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm   2.0 mm Cannulated Drill Bit / QC 150 mm  there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ.  No foreign distribution.   NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use.
ActCel  advanced bleeding control  Topical Hemostatic Dressing  2in X 2in (5cm X 5cm)  4in X 4in  Sterile Contents  Soluble Regenerated Cellulose  For Bleeding Control   For external topical and temporary use only  Sterility of contents guaranteed unless individual envelope is damaged or opened.  Store at room temperature (41F-104F).  Do not autoclave.
Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities.  ActCel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding.
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.
Zebeta (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by  Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
Failed Dissolution Specifications: OOS result during stability testing
AL, AZ,  AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR,  PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel,  Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA  19053-8433
Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.