FDAFDA · Food and drugs·Recall number D-0037-2016
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
Published October 21, 2015 · Recall initiated: July 28, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ohm Laboratories, Inc.
- Distributor
- Nationwide.
- Lot
- Batch Numbers: (a) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, Exp 9/30/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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