Class II · Moderate risk Ongoing
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
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Class II · Moderate risk Ongoing
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients…
Reason cGMP deviations
Class II · Moderate risk Ongoing
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA…
Reason cGMP deviations
Class II · Moderate risk Ongoing
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and…
Reason cGMP deviations
Class II · Moderate risk Ongoing
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…
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401…
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals…
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II · Moderate risk Ongoing
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Ongoing
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton…
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC…
Reason 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
Class II · Moderate risk Ongoing
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…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics…
Reason Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Class II · Moderate risk Ongoing
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…
Reason Lack of Assurance of Sterility