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Recall Observatory FDA recall evidence

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

July 28, 2015

Class III

Product summary

Firm
Ohm Laboratories, Inc.
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

    reason.potency_specification_failure · v1.0.0

    Superpotent