Drug product
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
D-0032-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 311 boxes
- Official record key
drug-enforcement:D-0032-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent