Home / Recalls / ULTRAtab Laboratories, Inc. / D-0526-2022

D-0526-2022 Class II Terminated

Recalled by ULTRAtab Laboratories, Inc. — Highland, NY

Recall Details

Product Type: Drugs
Report Date: February 16, 2022
Initiation Date: January 26, 2022
Termination Date: January 7, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 639,729 tablets

Product Description

Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00

Reason for Recall

CGMP Deviations

Distribution Pattern

Bulk product was distributed to 3 distributors who may have distributed finished product.

Code Information

Product Codes: C119L Bulk Lots: 18K028

Other recalls by ULTRAtab Laboratories, Inc.

D-0542-2022 Class II — Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab (January 26, 2022)
D-0546-2022 Class II — Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULT (January 26, 2022)
D-0537-2022 Class II — APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laborator (January 26, 2022)
D-0534-2022 Class II — Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora (January 26, 2022)
D-0555-2022 Class II — Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, U (January 26, 2022)
D-0532-2022 Class II — Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, (January 26, 2022)
D-0554-2022 Class II — DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets (January 26, 2022)
D-0530-2022 Class II — APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), (January 26, 2022)
D-0540-2022 Class II — Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labora (January 26, 2022)
D-0552-2022 Class II — Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRA (January 26, 2022)