FDA recall D-1142-2015

Product

Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-05-04

Report date

2015-06-24

Termination date

2016-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1142-2015