Drug product
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
D-0033-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,232 boxes
- Official record key
drug-enforcement:D-0033-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2600126, Exp 2/29/2016; 2644273, Exp 9/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent