Ohm Laboratories, Inc. recalls Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health,…
- Recall date
- July 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0030-2016
- 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
Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
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