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Showing 2281–2300 of 3363 results

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Nabumetone 750mg Tablets (Teva) – Labeling Issue (2015)

Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.

FDANov 19, 2015Nationwide• Teva Pharmaceuticals USA

Frozen Kingfish Steak (President East) - product decomposition (2015)

Recent FDA analysis determined that the product is decomposed and was also identified as Spanish mackerel.

FDANov 19, 2015NY• President East Company

Island Biscuit Yum Yum Strawberry (Lee's Food Corp) – undeclared colors (2015)

Undeclared Allergen

Sampling analysis revealed the product contains undeclared colors (FD&C Red #3 and Red #40).

Class IIILow

FDANov 13, 2015NJ, NY• Lee'S Food Corp

McGriddles Hot Cakes (Pioneer Frozen Foods) – water contamination (2015)

Rain water from the roof and water condensate dripped onto baked product and the conveyor belt in the production areas. Third party analysis revealed a high APC count.

FDANov 11, 2015GA, IA, KS +2 more• Pioneer Frozen Foods, Inc

Colostrum Powder (Immuno-Dynamics) – Undeclared Milk (2015)

The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.

FDANov 10, 2015Nationwide• Immuno - Dynamics, Inc

PerCoBa Colostrum Capsules (Immuno-Dynamics) – Undeclared Milk (2015)

The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.

FDANov 10, 2015Nationwide• Immuno - Dynamics, Inc

Prednisone Tablet (Northwind) – Incorrect Labeling (2015)

Labeling: Not elsewhere classified. NDC number is incorrect on the container.

FDANov 10, 2015Nationwide• Northwind Pharmaceuticals LLC

Colostrum Lozenges (Immuno-Dynamics) – Undeclared Milk (2015)

The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.

FDANov 10, 2015Nationwide• Immuno - Dynamics, Inc

PerCoBa Whey Protein (Immuno-Dynamics) – Undeclared Milk (2015)

The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.

FDANov 10, 2015Nationwide• Immuno - Dynamics, Inc

Paricalcitol Capsules (Dr. Reddy's) – Capsule Failure (2015)

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

FDANov 4, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Paricalcitol Capsules (Dr. Reddy's) – Capsule Failure (2015)

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

FDANov 4, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Swai Fillets (Restaurant Depot) – Nitrofuran Detection (2015)

Nitrofuran (SCA) was found in the product during routine third party lab testing.

FDANov 4, 2015FL, IN• Restaurant Depot/Jetro

Paricalcitol Capsules (Dr. Reddy's) – Capsule Failure (2015)

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

FDANov 4, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Meclizine Tablets (Mylan) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

FDANov 2, 2015Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Magnesium Sulfate (Avantor) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: Out of specifications results for impurities.

FDAOct 30, 2015CA, IL, IN +1 more• Avantor Performance Materials Inc

Epsom Salt (PQ Corporation) – Iron Impurity (2015)

Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).

FDAOct 29, 2015KY• PQ Corporation

Food Lion Cheese Pizza (Frozen Specialties) – kosher symbol issue (2015)

The product contains the Kosher symbol on its retail packaging. This symbol is a trademark of the Orthodox Union representing Kosher status. None of our products are not Kosher.

FDAOct 28, 2015NY, NC, PA +2 more• Frozen Specialties Inc

Food Lion Cheese Pizza (Frozen Specialties) – kosher symbol issue (2015)

The product contains the Kosher symbol on its retail packaging. This symbol is a trademark of the Orthodox Union representing Kosher status. None of our products are not Kosher.

FDAOct 28, 2015NY, NC, PA +2 more• Frozen Specialties Inc

Hannaford Cheese Pizza (Frozen Specialties) – kosher symbol issue (2015)

The product contains the Kosher symbol on its retail packaging. This symbol is a trademark of the Orthodox Union representing Kosher status. None of our products are not Kosher.

FDAOct 28, 2015NY, NC, PA +2 more• Frozen Specialties Inc

Meclizine Hydrochloride Tablets (Par Pharmaceutical) – impurity specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

FDAOct 26, 2015Nationwide• Par Pharmaceutical Inc.

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