| Jan 24, 2022 |
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylep... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium ... |
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 |
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-coun... |
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 |
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, package... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count pac... |
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 |
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-co... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffein... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, ... |
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 |
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Di... |
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 |
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HC... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (aceta... |
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 |
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 ... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 capl... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... |
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 |
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide ... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count pa... |
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 |
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... |
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 |
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distribute... |
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 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 11, 2022 |
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The L... |
cGMP deviations |
Class II |
Pharmasol Corporation |
| 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 |
| Dec 30, 2021 |
Metformin 750 mg Extended Release NDC # 70518-2920-00 |
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... |
Class II |
RemedyRepack Inc. |
| Dec 27, 2021 |
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ... |
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... |
Class II |
VIONA PHARMACEUTICALS INC |
| Dec 6, 2021 |
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial ... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... |
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... |
Class II |
Medique Products |
| Dec 6, 2021 |
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |
| Dec 6, 2021 |
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... |
CGMP Deviations |
Class II |
Edge Pharma, LLC |