FDA recall D-0023-2016

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2015-07-28

Report date

2015-10-21

Termination date

2016-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2016