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Showing 2921–2940 of 14370 results

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Dexamethasone Elixir (Morton Grove) – Unknown Impurity Levels (2022)

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Class IIModerate

FDAFeb 21, 2022Nationwide• Morton Grove Pharmaceuticals, Inc.

Family Dollar Dietary Supplements (Dollar Tree) - Rodent Exposure (2022)

Potential exposure to rodents and rodent activity in the distribution center.

Class IIModerate

FDAFeb 18, 2022AL, AR, LA +3 more• Dollar Tree Distribution, Inc.

Sapropterin Dihydrochloride (Dr. Reddy's) – Subpotent Drug (2022)

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

Class IIILow

FDAFeb 17, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Olanzapine Tablets (Macleods Pharma) – CGMP Deviation (2022)

cGmp Deviations

Class IIModerate

FDAFeb 16, 2022Nationwide• Macleods Pharma Usa Inc

Pyrazinamide Tablets (ANI Pharmaceuticals) – CGMP Deviation (2022)

cGMP Deviations

Class IIModerate

FDAFeb 15, 2022Nationwide• ANI Pharmaceuticals, Inc.

Alprazolam Tablets 0.5mg (ANI Pharmaceuticals) – CGMP Deviation (2022)

cGMP Deviations

Class IIModerate

FDAFeb 15, 2022Nationwide• ANI Pharmaceuticals, Inc.

Amlodipine Olmesartan Tablets (Macleods Pharma) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDAFeb 15, 2022Nationwide• Macleods Pharma Usa Inc

Alprazolam Tablets 0.25mg (ANI Pharmaceuticals) – CGMP Deviation (2022)

cGMP Deviations

Class IIModerate

FDAFeb 15, 2022Nationwide• ANI Pharmaceuticals, Inc.

Alprazolam Tablets 2.0mg (ANI Pharmaceuticals) – CGMP Deviation (2022)

cGMP Deviations

Class IIModerate

FDAFeb 15, 2022Nationwide• ANI Pharmaceuticals, Inc.

Alprazolam Tablets 1.0mg (ANI Pharmaceuticals) – CGMP Deviation (2022)

cGMP Deviations

Class IIModerate

FDAFeb 15, 2022Nationwide• ANI Pharmaceuticals, Inc.

Norepinephrine Bitartrate (BayCare) – Subpotent Drug (2022)

Subpotent drug

FDAFeb 14, 2022FL• BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

HCG Injection (Revive Rx) – Bacterial Contamination (2022)

Non-sterility; bacterial contamination identified as Paenibacillus lautus.

FDAFeb 11, 2022Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

RISE UP RED EDITION Capsules (Positive Health) – Undeclared Ingredient (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

FDAFeb 10, 2022Nationwide• Positive Health

Avaphinal Male Enhancement Pills (Walmart) – Undeclared Sildenafil (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

FDAFeb 9, 2022Nationwide• Walmart Stores

Diazepam Oral Solution (Lannett) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Class IIModerate

FDAFeb 9, 2022Nationwide• Lannett Company, Inc.

MAC DADDY PURPLE Capsules (ABC Sales) – Undeclared Ingredients (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

FDAFeb 8, 2022Nationwide• ABC Sales 1 Inc

MAC DADDY RED Capsules (ABC Sales) – Undeclared Ingredients (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

FDAFeb 8, 2022Nationwide• ABC Sales 1 Inc

RED MAMMOTH Capsules (Celebrate Today) – Undeclared Ingredients (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

FDAFeb 8, 2022Nationwide• Celebrate Today

THE RED PILL Capsules (Your Favorite Shop) – Undeclared Tadalafil (2022)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

FDAFeb 8, 2022Nationwide• Your Favorite Shop

Erythromycin Topical Gel (Teligent) – Impurity Specification Failure (2022)

Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.

Class IIModerate

FDAFeb 7, 2022Nationwide• Teligent Pharma, Inc.

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