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Showing 921–940 of 3363 results

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Dextroamphetamine Mixture (ANI) – Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Desflurane Liquid (eVenus) - Container Leak (2020)

DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.

FDAOct 6, 2020CO• eVenus Pharmaceutical Laboratories

Candesartan-Hydrochlorothiazide Tablets (Mylan) – Impurity Issue (2020)

Out-of-specification organic impurity results obtained during routine stability testing.

FDAOct 2, 2020Nationwide• Mylan Pharmaceuticals Inc.

Fluocinonide Ointment (Teligent Pharma) – Impurity Failure (2020)

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

FDASep 28, 2020Nationwide• Teligent Pharma, Inc.

Nystatin Oral Suspension (VistaPharm) – Impurity Specification (2020)

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

FDASep 25, 2020Nationwide• VistaPharm, Inc.

Metformin Hydrochloride Tablets (Legacy Packaging) – Foreign Tablets (2020)

Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.

FDASep 24, 2020AR, GA, IN• Legacy Pharmaceutical Packaging LLC

Cystaran (Leadiant Biosciences) – Subpotent Drug (2020)

Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

FDASep 24, 2020PA• Leadiant Biosciences, Inc.

Homeopathic Energy Catalyst (Grato Holdings) – Incorrect Labeling (2020)

Undeclared Allergen

Labeling: Product Contains Undeclared API; Incorrect formulation

FDASep 17, 2020UT• Grato Holdings, Inc.

Nymalize (Arbor Pharmaceuticals) – Subpotent Drug (2020)

Subpotent Drug

FDASep 16, 2020Nationwide• Arbor Pharmaceuticals Inc.

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

FDASep 9, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nicotine Gum (P & L Developments) – Missing Package Insert (2020)

Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.

FDASep 9, 2020Nationwide• P & L Developments, LLC

Tailgate Tacos Potato Chips (Herr's) - Undeclared Ingredients (2020)

Undeclared Allergen

Undeclared black bean powder, jalapeno pepper powder, paprika, extract of paprika and disodium inosinate and disodium guanylate.

FDASep 3, 2020IL, IA, MD +3 more• Herr Foods Inc

Crab Soft Shell Tempura (Wegmans) – Listeria contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

Crab Cake (Wegmans) – Listeria contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

AIP Veggie Pizza (Wegmans) – Listeria contamination (2020)

Products are potentially contaminated with Listeria monocytogenes.

FDAAug 7, 2020MD, NJ, NY +3 more• Wegmans Food Markets, Inc.

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