Class II · Moderate risk Terminated
Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61
Reason cGMP deviations: Temperature abuse
Pain Relief & OTC Medication Recalls
Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Class II · Moderate risk Completed
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use…
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred…
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals…
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey…
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories…
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00
Reason CGMP Deviations
Class II · Moderate risk Terminated
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc…
Reason CGMP Deviations
Class II · Moderate risk Terminated
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk…
Reason CGMP Deviations
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