Ohm Laboratories, Inc. recalls Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01…
- Recall date
- July 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0037-2016
- 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
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
Get recall alerts
Free email alert whenever Ohm Laboratories, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Ohm Laboratories, Inc.