| Jan 24, 2022 |
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg),... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count pac... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Jus... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dis... |
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 |
DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, package... |
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 |
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Di... |
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 |
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distribute... |
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 |
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 ... |
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 |
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 t... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin ... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110... |
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 |
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 |
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 |
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 |
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 24, 2022 |
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in... |
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 |
PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b... |
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 |
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3... |
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 |
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, ... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Dec 15, 2021 |
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... |
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria |
Class I |
Taro Pharmaceuticals U.S.A., Inc. |
| Dec 6, 2021 |
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... |
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... |
Class I |
Valisa MFG LLC |
| Nov 30, 2021 |
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... |
Lack of sterility assurance: bag has the potential to leak. |
Class II |
Pfizer Inc. |
| Nov 29, 2021 |
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... |
CGMP Deviations: failed stability results, inadequate laboratory investigations, |
Class II |
ULTRAtab Laboratories, Inc. |
| Nov 19, 2021 |
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... |
Product Mix-up |
Class II |
Ascent Pharmaceuticals, Inc. |
| Nov 12, 2021 |
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... |
Lack of Assurance of Sterility |
Class II |
SterRx, LLC |
| Nov 12, 2021 |
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... |
Lack of Assurance of Sterility |
Class II |
SterRx, LLC |
| Nov 12, 2021 |
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... |
Lack of Assurance of Sterility |
Class II |
SterRx, LLC |
| Nov 12, 2021 |
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... |
Lack of Assurance of Sterility |
Class II |
SterRx, LLC |