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Showing 1–20 of 21 results

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Mint Flavored Tablets (Eskay Brands) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Lifted Made-Lemon Tablet (Eden's Elixirs) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Mint Flavored Tablets (Lifted Made) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class II

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Fluoxetine Tablets (Torrent Pharma) - CGMP Nitrosamine Deviation (2025)

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

FDAMay 27, 2025Nationwide• Torrent Pharma Inc.

Irbesartan Tablets 300mg (AvKARE) – Dissolution Issue (2025)

Out of Specification for Dissolution

FDAJan 21, 2025Nationwide• AvKARE

Calcium Carbonate Chewable (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

FDANov 11, 2024Nationwide• Safecor Health, LLC

Pyrazinamide Tablet 500mg (RemedyRepack) – Quality Program Issue (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

FDAMay 1, 2023IN, PA• RemedyRepack Inc.

Ready in Case Allergy Tablets (Family Dollar) – Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Pepcid Complete Chewable Tablets (Family Dollar) – Storage Temperature Deviation (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Dulcolax Tablets (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Claritin Allergy Liquid (Family Dollar) – Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Jet Alert Tablets (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

QP LAXATIVE BISACODYL 5 MG TABLET (Family Dollar Stores, Llc.) – cgmp deviations: product held outside... (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

My Choice Levonorgestrel Tablet (Family Dollar) – Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

QP MOTION SICKNESS TABLET (Family Dollar Stores, Llc.) – cgmp deviations: product held outside... (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

QP COUGH COLD TABLET (Family Dollar Stores, Llc.) – cgmp deviations: product held outside... (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Guardian Antacid Tablets (Family Dollar) – Storage Temperature Deviation (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Mucinex Mucus Relief Tablets (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Good Sense Omeprazole Tablets (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Ranitidine Tablets (Granules India) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

FDADec 13, 2019NJ, NY, OR• Granules India Limited

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