Drug product
Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
D-0020-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 90,410 units
- Official record key
drug-enforcement:D-0020-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: a) 2658137, Exp 11/30/2016; 2644272, Exp 9/30/2016; 2625093, 2625092 Exp 6/30/2016; 2617892, Exp 5/31/2016; 2610783, Exp 4/30/2016; 2600126, 2600128, Exp 2/29/2016 b) 2625093, Exp 6/30/2016; 2617892, Exp 5/31/2016; 2600128, Exp 2/29/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent