Home / Recalls / ULTRAtab Laboratories, Inc. / F-0727-2022

F-0727-2022 Class II Terminated

Recalled by ULTRAtab Laboratories, Inc. — Highland, NY

Recall Details

Product Type
Food
Report Date
February 16, 2022
Initiation Date
October 6, 2021
Termination Date
September 1, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,853,539 tablets

Product Description

Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Reason for Recall

cGMP Deviations

Distribution Pattern

Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

Code Information

Product Codes: M976 Bulk Lots: 19B050, 19F063

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-0546-2022 Class II — Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULT (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-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-0552-2022 Class II — Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 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)