Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Cont... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Pheny... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, U... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTR... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Cont... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland,... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, U... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC ... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, N... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, ... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Hig... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, ... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highla... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Con... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc.,... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Hig... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., High... Jan 26, 2022 FDA drug enforcement
CGMP Deviations
Class II Reported terminated
Distribution: Bulk product was distributed to 3 distributors who may have distributed finished product.
Official source for Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., ...