Recalls / Class II
Class IID-0506-2022
Product
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
- Affected lot / code info
- Lot #: 19C038C, Exp. Date 03/2022; 19G047C, Exp. Date 07/2022; 18L124C, Exp. Date 02/2022
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Ultra Seal Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 521 Main St, N/A, New Paltz, New York 12561-1609
Distribution
- Quantity
- 90,072 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-01-24
- FDA classified
- 2022-01-31
- Posted by FDA
- 2022-02-09
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0506-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.