Drug product
Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.
D-0024-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,176 units
- Official record key
drug-enforcement:D-0024-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2617892, Exp 5/31/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent