February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufa
Hazard: Mislabeling
February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manuf
Hazard: Mislabeling
February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-08
Hazard: Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corp
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Bo
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithf
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Produc
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products US
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Sea
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephr
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth S
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet pa
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke,
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pha
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharm
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharm
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharm
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Cons
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet pa
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mf
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 6
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason,
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributo
Hazard: cGMP deviations
February 9, 2022DrugsFDA
Ultra Seal Corporation recalls PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Di
Hazard: cGMP deviations