FDA-Drug2015-10-21Class III

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9

Ohm Laboratories, Inc.
Hazard

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

Sold states
Nationwide.
Affected count
29,360 boxes
Manufactured in
1385 Livingston Ave, N/A, North Brunswick, NJ, United States
Products
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2016

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