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Showing 1961–1980 of 3363 results

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Bupropion Hydrochloride Tablets (Zydus) – Dissolution Failure (2016)

Failed Dissolution Specifications; 6 month time point

FDANov 2, 2016Nationwide• Zydus Pharmaceuticals USA Inc

Qnasl Nasal Aerosol 40mcg (Teva) – Content Uniformity (2016)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

FDANov 1, 2016Nationwide• Teva Pharmaceuticals USA

Qnasl Nasal Aerosol 80mcg (Teva) – Content Uniformity (2016)

Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.

Class IIILow

FDANov 1, 2016Nationwide• Teva Pharmaceuticals USA

KENALOG Spray (Sun Pharmaceutical) – Stability Specification Failure (2016)

Failed Stability Specifications: Low Out of Specification results for alcohol content.

FDAOct 28, 2016Nationwide• Sun Pharmaceutical Industries, Inc.

White Chicken Chili Dry Soup Mix (Simply Balanced) – Metal Contamination (2016)

Simply Balanced brand White Chili dry soup mix is recalled because it was contaminated with metal shavings.

FDAOct 28, 2016CA, IN, MI +6 more• Conifer Specialties, Inc.

Bupropion Hydrochloride XL 300mg (Amerisource) – Dissolution Specification Failure (2016)

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

FDAOct 27, 2016Nationwide• Amerisource Health Services

Original Glazed Doughnuts (Krispy Kreme) – plastic contamination (2016)

Possible piece of plastic in the product.

FDAOct 21, 2016VA• Krispy Kreme Doughnut Corporation

FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

FDAOct 20, 2016Nationwide• CutisPharma, Inc.

FIRST Omeprazole Suspension 2mg/mL (CutisPharma) – Labeling Error (2016)

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

FDAOct 20, 2016Nationwide• CutisPharma, Inc.

Ceftriaxone Injection 1g (Sandoz) – Missing Label (2016)

Labeling: Missing Label

FDAOct 19, 2016WI• Sandoz Inc

Invokamet (Janssen) – Incorrect Package Insert (2016)

Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.

FDAOct 19, 2016Nationwide• Janssen Ortho L.L.C.

HCG (Town and Country) – Subpotent Drug (2016)

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

FDAOct 18, 2016Nationwide• Town and Country Compounding and Consultation Services, LLC

Zeasorb AF (GSK) – Incorrect NDC Labels (2016)

Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".

FDAOct 18, 2016Nationwide• GSK Consumer Healthcare

Olanzapine Tablets (Dr. Reddy's) – Impurity Specification (2016)

Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.

FDAOct 13, 2016Nationwide• Dr. Reddy's Laboratories, Inc.

AHP NIFEdipine Capsules (Amerisource) – Foreign Tablets (2016)

Presence of Foreign Tablets/Capsules

FDAOct 13, 2016Nationwide• Amerisource Health Services

HCG-Vitamin B12 (Pharm D) – Strength Label Error (2016)

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

FDAOct 12, 2016AZ, WA• Pharm D Solutions, LLC

Testosterone Cypionate (Pharm D) – Incorrect Oil Description (2016)

Undeclared Allergen

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

FDAOct 12, 2016AZ, WA• Pharm D Solutions, LLC

NIFEdipine Capsules (Actavis) – Foreign Tablets (2016)

Presence of Foreign Tablets/Capsules

FDAOct 6, 2016Nationwide• Actavis Elizabeth LLC

Hollandaise Sauce (Rikki USA) – mold presence (2016)

Hollandaise Sauce was recalled due to presence of mold.

FDAOct 5, 2016IN, MD, OR• Rikki USA, Inc.

Amino Complex Formula Drops (Infiniti Creations) – misbranding risk (2016)

Undeclared Allergen

The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.

FDASep 30, 2016Nationwide• Infiniti Creations, LLC

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