Recalls / Class II
Class IIF-0727-2022
Product
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Type
- Food
- Affected lot / code info
- Product Codes: M976 Bulk Lots: 19B050, 19F063
- Quantity
- 5,853,539 tablets
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- ULTRAtab Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Toc Dr, N/A, Highland, New York 12528-1506
Distribution
- Distribution pattern
- Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Timeline
- Recall initiated
- 2021-10-06
- FDA classified
- 2022-02-09
- Posted by FDA
- 2022-02-16
- Terminated
- 2022-09-01
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0727-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.