Drug product
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA
D-0025-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43,344 boxes
- Official record key
drug-enforcement:D-0025-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: a) 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016; 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent