Ohm Laboratories, Inc. recalls Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceutic…
- Recall date
- July 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0031-2016
- FDA classification
- Class III
- Brand / firm
- Ohm Laboratories, Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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