Home / Recalls / ULTRAtab Laboratories, Inc. / D-0524-2022

D-0524-2022 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
19,103,287 tablets

Product Description

4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00

Reason for Recall

CGMP Deviations

Distribution Pattern

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

Code Information

Product Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067

Other recalls by ULTRAtab Laboratories, Inc.

  • D-0550-2022 Class II — Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRA (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)
  • D-0532-2022 Class II — Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, (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-0546-2022 Class II — Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULT (January 26, 2022)
  • D-0541-2022 Class II — Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laborat (January 26, 2022)
  • D-0542-2022 Class II — Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab (January 26, 2022)
  • D-0534-2022 Class II — Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora (January 26, 2022)
  • D-0545-2022 Class II — Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab L (January 26, 2022)