| Feb 4, 2022 |
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... |
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... |
Class II |
Professional Disposables International, Inc. |
| Feb 4, 2022 |
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters pa... |
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingr... |
Class I |
Junp Hydration LLC |
| 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 |
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| 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 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) ... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 ... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAta... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... |
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 26, 2022 |
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, UL... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| 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 |
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTR... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labo... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 26, 2022 |
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... |
CGMP Deviations |
Class II |
ULTRAtab Laboratories, Inc. |
| Jan 24, 2022 |
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet... |
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 |
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorp... |
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 |
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-coun... |
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 |
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffein... |
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 |
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg... |
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 |
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,... |
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 |
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by Z... |
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 (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Ma... |
cGMP deviations |
Class II |
Ultra Seal Corporation |