FDA-Drug2015-10-21Class III

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

Ohm Laboratories, Inc.
Hazard

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

Sold states
Nationwide.
Affected count
329,748 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0038-2016

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