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
Reported: October 21, 2015 Initiated: July 28, 2015 #D-0037-2016
Product Description
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
Reason for Recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Details
- Recalling Firm
- Ohm Laboratories, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide.
- Location
- North Brunswick, NJ
Frequently Asked Questions
What product 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. Recalled by Ohm Laboratories, Inc.. Units affected: N/A.
Why was this product recalled? ▼
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0037-2016.
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