Drug product
Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
D-0036-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 34,488 boxes
- Official record key
drug-enforcement:D-0036-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2617892, 2617893, Exp 5/31/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, Exp 11/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent