| Mar 21, 2025 |
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Ma... |
Lack of Assurance of Sterility: Media fill with bacterial contamination |
Class II |
Somerset Therapeutics Private Limited |
| Mar 21, 2025 |
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Via... |
Lack of Assurance of Sterility: Media fill with bacterial contamination |
Class II |
Somerset Therapeutics Private Limited |
| Mar 21, 2025 |
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesci... |
Presence of Foreign Substance: Product complaint received for the presence of foreign material em... |
Class II |
Zydus Pharmaceuticals (USA) Inc |
| Mar 17, 2025 |
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactu... |
Failed dissolution specifications: lower than specifications |
Class II |
BIOCON PHARMA INC |
| Mar 13, 2025 |
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... |
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... |
Class I |
Dr. Reddy's Laboratories, Inc. |
| Mar 13, 2025 |
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactur... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottl... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenma... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: ... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: ... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manuf... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, R... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: G... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufact... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactur... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: G... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenm... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), ... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufact... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured ... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenm... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 |
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottl... |
CGMP Deviations |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Mar 12, 2025 |
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Z... |
cGMP deviations |
Class II |
KABANA SKIN CARE |
| Mar 12, 2025 |
In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spec... |
cGMP deviations |
Class II |
KABANA SKIN CARE |
| Mar 12, 2025 |
Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), D... |
Chemical contamination: Presence of benzene |
Class II |
Alchemee, LLC |
| Mar 12, 2025 |
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Su... |
cGMP deviations |
Class II |
KABANA SKIN CARE |
| Mar 12, 2025 |
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Z... |
cGMP deviations |
Class II |
KABANA SKIN CARE |
| Mar 12, 2025 |
Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 ... |
Chemical contamination: Presence of benzene |
Class II |
Alchemee, LLC |