D-0506-2022 Class II Terminated
FDA drug recall D-0506-2022 was initiated by Ultra Seal Corporation on January 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated October 16, 2023). Affected quantity: 90,072 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 9, 2022
- Initiation Date
- January 24, 2022
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90,072 bottles
Product Description
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 19C038C, Exp. Date 03/2022; 19G047C, Exp. Date 07/2022; 18L124C, Exp. Date 02/2022