| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx ... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count ... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-coun... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx ... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx ... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Onl... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-coun... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx ... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx O... |
Subpotent Drug |
Class II |
| Aug 6, 2026 |
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count ... |
Subpotent Drug |
Class II |
| Jun 8, 2026 |
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx on... |
Subpotent Drug |
Class II |
| Sep 16, 2025 |
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... |
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets... |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Jun 20, 2025 |
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... |
Subpotent Drug: Assay below the approved specification |
Class II |
| Apr 10, 2025 |
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, ... |
Subpotent |
Class II |
| Apr 10, 2025 |
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, M... |
Subpotent |
Class II |
| Apr 10, 2025 |
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, M... |
Subpotent |
Class II |
| Apr 10, 2025 |
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, ... |
Subpotent |
Class II |
| Nov 8, 2024 |
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx O... |
Subpotent drug |
Class II |
| Oct 10, 2024 |
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... |
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... |
Class II |
| Oct 10, 2024 |
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... |
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... |
Class II |
| Oct 10, 2024 |
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... |
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... |
Class II |
| Oct 1, 2024 |
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... |
Failed Impurities/Degradation Specifications. |
Class II |
| Jun 18, 2024 |
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... |
Subpotent drug: out of specification results |
Class III |
| Jul 3, 2023 |
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... |
Presence of Particulate Matter: Particulate matter identified as fiber. |
Class II |
| Jul 3, 2023 |
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... |
Presence of Particulate Matter: Particulate matter identified as fiber. |
Class II |
| Mar 29, 2023 |
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... |
Sub-potent drug: assay test result below specifications at 9-month timepoint. |
Class III |
| Feb 7, 2023 |
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC ... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 ... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufa... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
| Feb 7, 2023 |
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactur... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |