Home / Recalls / ULTRAtab Laboratories, Inc. / D-0528-2022

D-0528-2022 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
14,566,510 tablets

Product Description

Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00

Reason for Recall

CGMP Deviations

Distribution Pattern

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

Code Information

Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042

Other recalls by ULTRAtab Laboratories, Inc.

  • D-0532-2022 Class II — Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, (January 26, 2022)
  • D-0546-2022 Class II — Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULT (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-0552-2022 Class II — Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRA (January 26, 2022)
  • D-0550-2022 Class II — Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRA (January 26, 2022)
  • D-0545-2022 Class II — Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab L (January 26, 2022)
  • D-0540-2022 Class II — Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labora (January 26, 2022)
  • D-0529-2022 Class II — APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories (January 26, 2022)
  • D-0539-2022 Class II — Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab La (January 26, 2022)