Ohm Laboratories, Inc. recalls Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug…
- Recall date
- July 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0033-2016
- 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
Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
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