| Dec 30, 2025 |
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercar... |
Defective container: Preferred Pharmaceuticals received a letter from the man... |
Class II |
| Nov 21, 2025 |
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... |
Cross Contamination with Other Products: Testing of reserve samples showed pr... |
Class III |
| Nov 18, 2025 |
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... |
Cross Contamination with Other Products |
Class III |
| Sep 17, 2025 |
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... |
CGMP Deviations: Market complaints received for gritty texture (grainy) |
Class II |
| Sep 3, 2025 |
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl... |
Failed Impurities/Degradation Specifications |
Class II |
| Aug 8, 2025 |
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... |
Failed Dissolution Specifications: Failure results (above) were reported for ... |
Class II |
| Aug 7, 2025 |
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... |
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity... |
Class II |
| Aug 7, 2025 |
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... |
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity... |
Class II |
| Aug 7, 2025 |
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... |
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity... |
Class II |
| Aug 6, 2025 |
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... |
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ... |
Class II |
| Aug 6, 2025 |
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... |
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ... |
Class II |
| May 19, 2025 |
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... |
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for ... |
Class III |
| May 15, 2025 |
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bo... |
OOS results reported for the Dissolution (by UV) test. |
Class II |
| Mar 13, 2025 |
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufact... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenm... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), ... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenm... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, R... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: G... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactur... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured ... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufact... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottl... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: G... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottl... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: ... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: ... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenma... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactur... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... |
CGMP Deviations |
Class II |
| Mar 13, 2025 |
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... |
CGMP Deviations |
Class II |