Drug product
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
D-1142-2015
Product summary
- Event
- Event 71334
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2592 Blister Packs
- Official record key
drug-enforcement:D-1142-2015
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Lot #: 2625094, Exp 06/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent