D-0505-2022 Class II Terminated
FDA drug recall D-0505-2022 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: 241,560 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
- 241,560 bottles
Product Description
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 18L124, Exp. Date 02/2022; 19D029, Exp. Date 04/2022