Prescription medicine recalls

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · N/A affected

Glenmark Pharmaceuticals Inc., USA — Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only

CGMP Deviations

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · N/A affected

Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only

CGMP Deviations

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · N/A affected

Glenmark Pharmaceuticals Inc., USA — Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only

CGMP Deviations

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · N/A affected

Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

CGMP Deviations

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · N/A affected

Glenmark Pharmaceuticals Inc., USA — Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only

CGMP Deviations

Food & drug recall · FDAMarch 12, 2025Serious

Alchemee, LLC — Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1

Prescription medicine · Alchemee, LLC · 3,500 bottles affected

Chemical contamination: Presence of benzene

Food & drug recall · FDAMarch 12, 2025Serious

Alchemee, LLC — Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g)

Prescription medicine · Alchemee, LLC · 38,237 bottles affected

Chemical contamination: Presence of benzene

Prescription medicine · Fruit Of The Earth, Inc. · 100,970 tubes affected

Fruit Of The Earth, Inc. — Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton

Chemical contamination: presence of benzene

Prescription medicine · Fruit Of The Earth, Inc. · 112045 tubes affected

Fruit Of The Earth, Inc. — CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g)

Chemical contamination: presence of benzene

Prescription medicine · FDC Limited · 90960 bottles affected

FDC Limited — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 8160 bottles affected

Glenmark Pharmaceuticals Inc., USA — chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Prescription medicine · Exela Pharma Sciences LLC · 103,950 vials affected

Exela Pharma Sciences LLC — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only

Lack of Assurance of Sterility

Prescription medicine · ASEGUA THERAPEUTICS LLC · 18,541 cartons. affected

ASEGUA THERAPEUTICS LLC — Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Prescription medicine · Mylan Institutional, Inc. · 347 Cartons affected

Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 5107

Super-Potent Drug: Out of specification potency results were obtained.

Prescription medicine · Slate Run Pharmaceuticals · 2,444 bottles affected

Slate Run Pharmaceuticals — Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Prescription medicine · Mylan Institutional, Inc. · 1,068 cartons affected

Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 510

Super-Potent Drug: Out of specification potency results were obtained.

Prescription medicine · Direct Rx · 16 bottles affected

Direct Rx — Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Prescription medicine · Direct Rx · 875 bottles affected

Direct Rx — Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Prescription medicine · Slate Run Pharmaceuticals · 56,790 bottles affected

Slate Run Pharmaceuticals — Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.