Ohm Laboratories, Inc. recalls Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01,
Recalled October 21, 2015 · FDA recall D-0037-2016 · Ohm Laboratories
Hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay. · FDA Class III
Units
N/A
Sold at
Nationwide.
Description
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Product
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
Manufacturer(s)
Ohm Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →