Ohm Laboratories, Inc. recalls Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-
Recalled October 21, 2015 · FDA recall D-0038-2016 · Ohm Laboratories
Hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay. · FDA Class III
Units
329,748 boxes
Sold at
Nationwide.
Description
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Product
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015
Manufacturer(s)
Ohm Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →