Drug product
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
D-0022-2016
Product summary
- Event
- Event 71973
- Status
- Terminated
- Classification
- Class III
- Quantity
- 21,356 boxes
- Official record key
drug-enforcement:D-0022-2016
Official wording
Reason: Superpotent Drug: Out Of Specification (OOS) result for Assay.
Code information: Batch Numbers: (a) 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent