QC Quality Choice Loratadine Orally Disintegrating Tablets — Class III drug recall D-0019-2016
Terminated recall by Ohm Laboratories, Inc., reported 2015-10-21, distributed nationwide. Superpotent Drug: Out Of Specification (OOS) result for Assay.
| Recall number | D-0019-2016 |
|---|---|
| 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) |
| Quantity | 8,735 units |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00635515957770 |
| NDC | 63868-0157-10 |
| Lot numbers | 2544486, 2600127, 2644273 |
| Expiration dates | 2016-03-20, 2016-07-31, 2016-09-30 |
Product
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
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-0019-2016. 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.