Drug product
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
D-0019-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,735 units
- Official record key
drug-enforcement:D-0019-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2644273, Exp 9/30/2016; 2600127, Exp 3/20/2016; 2544486, Exp 7/31/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent