Drug product
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
D-0023-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 291,312 boxes
- Official record key
drug-enforcement:D-0023-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: a) 2644273, 2644265, Exp 9/30/2016; 2617891, 2617892, 2617893, Exp 5/31/2016; 2625093, 6/30/2016; 2544488, 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2610783, Exp 4/30/2016 b) 2600128, Exp 2/29/2016; 2544487, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016; 2644272, Exp 9/30/2016; 2658138, Exp 11/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent