Drug product
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
D-0034-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 33,984 boxes
- Official record key
drug-enforcement:D-0034-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: a) 2658140, Exp 11/30/2016; 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; b) 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent