PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 21, 2015 Initiated: July 28, 2015 #D-0023-2016

Product Description

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

Reason for Recall

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Details

Recalling Firm
Ohm Laboratories, Inc.
Units Affected
291,312 boxes
Distribution
Nationwide.
Location
North Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Ohm Laboratories, Inc.. Units affected: 291,312 boxes.
Why was this product recalled?
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0023-2016.