| Jan 26, 2022 |
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured b... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| 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 |
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Ma... |
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 |
Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5... |
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 |
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in... |
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 |
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... |
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 |
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... |
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 |
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenyleph... |
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 |
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnes... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD ... |
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 |
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)... |
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 |
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5... |
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 |
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bott... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by Z... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afas... |
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 |
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,... |
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 |
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distribute... |
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 |
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 m... |
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 |
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg),... |
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 |
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffein... |
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 |
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110... |
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 |