Home / Recalls / ULTRAtab Laboratories, Inc. / F-0726-2022

F-0726-2022 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
955,928 tablets

Product Description

Melatonin ER 0.5 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: M975 Bulk Lots: 19E058

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)