Sunmark loratadine Orally Disintegrating Tablets — Class III drug recall D-0037-2016
Terminated recall by Ohm Laboratories, Inc., reported 2015-10-21, distributed nationwide. Superpotent Drug: Out Of Specification (OOS) result for Assay.
| Recall number | D-0037-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ohm Laboratories, Inc., North Brunswick, NJ, United States |
| Recall initiated | 2015-07-28 |
| Classified | 2015-10-15 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-10-28 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 49348-0930-01, 49348-0930-44 |
| Lot numbers | 2544488, 2617893, 2644273, 26917891 |
| Expiration dates | 2016-05-31, 2016-07-31, 2016-09-30 |
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 for recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0037-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.