Drug product
Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
D-0030-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,624 boxes
- Official record key
drug-enforcement:D-0030-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent