FDA Drug recall 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)
- FDA Drug
- Class III
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class III recall of Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6) by Ohm Laboratories, citing superpotent Drug: Out Of Specification (OOS) result for Assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0037-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-28 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ohm Laboratories |
| Distribution | US |
Product
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
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Identifiers
| upc | 010939365446 |
|---|---|
| upc | 010939349446 |
| code_info | 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0037-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.