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Showing 4181–4200 of 14370 results

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BTREX PLUS Dietary Supplement (Lopez Gonzalez) – damaged tablets (2020)

CGMP Deviations: Presence of damaged tablets

Class IIILow

FDAJul 13, 2020PR• Lopez Gonzalez Santana Corporation

BTREX PLUS Dietary Supplement (Lopez Gonzalez) – damaged tablets (2020)

CGMP Deviations: Presence of damaged tablets

Class IIILow

FDAJul 13, 2020PR• Lopez Gonzalez Santana Corporation

Modesa Hand Sanitizer (4e Brands) – Manufacturing Risk (2020)

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

Class IIModerate

FDAJul 11, 2020Nationwide• 4e Brands North America, Llc

Assured Hand Sanitizer (4e Brands) – Manufacturing Risk (2020)

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

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BTREX PLUS Dietary Supplement (Lopez Gonzalez) – damaged tablets (2020)

BTREX PLUS Dietary Supplement (Lopez Gonzalez) – damaged tablets (2020)

Modesa Hand Sanitizer (4e Brands) – Manufacturing Risk (2020)

Assured Hand Sanitizer (4e Brands) – Manufacturing Risk (2020)

Auryxia Tablets (Keryx Biopharmaceuticals) – Manufacturing Deviation (2020)

Metformin Hydrochloride Extended-Release 500mg (Lupin) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release 1000mg (Lupin) – NDMA Impurity (2020)

Daptomycin for Injection (Mylan) – Particulate Matter (2020)

Metformin Hydrochloride Extended-Release 500mg (Lupin) – NDMA Impurity (2020)

Metformin Hydrochloride Extended-Release 1000mg (Lupin) – NDMA Impurity (2020)

Clonazepam Orally Disintegrating Tablets (Sun Pharmaceutical) – Cross Contamination (2020)

Metformin Hydrochloride Extended-Release 750mg (Granules) – NDMA Impurity (2020)

Estriol 6 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Estriol 8 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Tadalafil 18 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Tadalafil 3 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Minoxidil/Biotin/Spironolactone Capsules (MasterPharm) – Processing Controls Issue (2020)

Progesterone Modified Release 150 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Progesterone Modified Release 200 mg Capsule (MasterPharm) – Processing Controls Issue (2020)

Cefdinir Oral Suspension (Lupin) – Superpotent Drug Result (2020)