| Jan 26, 2022 |
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 26, 2022 |
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| 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 |
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 |
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Conta... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered In... |
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... |
Class II |
CARDINAL HEALTHCARE |
| Jan 24, 2022 |
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dis... |
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 |
Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5... |
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 |
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg),... |
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 |
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD ... |
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 |
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,... |
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 |
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count pac... |
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 |
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (aceta... |
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 |
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in... |
cGMP deviations |
Class II |
Ultra Seal Corporation |
| Jan 24, 2022 |
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorp... |
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 |
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... |
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 |
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, ... |
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 |
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... |
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 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 |
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,... |
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 |
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 |
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in... |
cGMP deviations |
Class II |
Ultra Seal Corporation |