Ohm Laboratories, Inc. recalls Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-5…
- Recall date
- July 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0034-2016
- 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
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
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