| Jan 24, 2022 |
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco I... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, G... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-co... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenyleph... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count pac... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd.... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine ... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnes... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg)... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, pa... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bott... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 m... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 21, 2022 |
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) top... |
cGMP deficiencies |
Class II |
Mylan Pharmaceuticals Inc |
| Jan 19, 2022 |
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... |
Failed stability specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 |
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... |
Failed stability specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 |
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... |
Failed stability specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2022 |
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... |
Failed Dissolution Specification: Dissolution results are below specification limits for the acti... |
Class II |
Teva Pharmaceuticals USA |
| Jan 14, 2022 |
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only... |
Failed Impurities/Degradation Specifications |
Class II |
Aurobindo Pharma USA Inc. |
| Jan 14, 2022 |
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY,... |
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. |
Class II |
Mayne Pharma Inc |
| Jan 12, 2022 |
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... |
Failed Dissolution Specifications. |
Class II |
Ascend Laboratories, LLC |
| Jan 11, 2022 |
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The L... |
cGMP deviations |
Class II |
Pharmasol Corporation |
| Jan 11, 2022 |
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, ... |
Lack of Assurance of Sterility |
Class II |
Exela Pharma Sciences LLC |
| Jan 10, 2022 |
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)... |
CGMP Deviations |
Class II |
Ingenus Pharmaceuticals Llc |
| Jan 10, 2022 |
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... |
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. |
Class II |
Teva Pharmaceuticals USA |
| Jan 10, 2022 |
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... |
Subpotent drug |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 7, 2022 |
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... |
Failed Stability Specifications |
Class II |
VistaPharm, Inc. |
| Jan 7, 2022 |
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... |
Mislabeling |
Class III |
Teva Pharmaceuticals USA |
| Jan 7, 2022 |
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... |
Mislabeling |
Class III |
Teva Pharmaceuticals USA |
| Jan 5, 2022 |
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pe... |
Labeling: Missing Label: label missing from some Semglee prefilled pens. |
Class I |
Mylan Pharmaceuticals Inc |
| Jan 5, 2022 |
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous an... |
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. |
Class II |
Akorn, Inc. |
| Jan 4, 2022 |
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Jan 4, 2022 |
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... |
Failed Dissolution Specifications |
Class III |
Dr. Reddy's Laboratories, Inc. |
| Dec 31, 2021 |
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... |
Lack of Assurance of Sterility |
Class II |
Teva Pharmaceuticals USA |