Drug product
Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
D-0021-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18576 boxes
- Official record key
drug-enforcement:D-0021-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2625092, Exp 6/30/2016; 2644265, Exp 9/30/2016; 2600126, Exp 2/29/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent