Orphenadrine Citrate Extended Release Tablets — Class III drug recall D-1445-2014
Terminated recall by Sandoz Inc, reported 2014-07-30, distributed nationwide. Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
| Recall number | D-1445-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2014-07-11 |
| Classified | 2014-07-23 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2017-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 781,000 extended |
| Reason classes | specification failure |
| NDC | 00185-0022, 00185-0022-01, 00185-0022-10 |
| Lot numbers | 05/16, DM1316, DM1318 |
Product
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Reason for recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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-1445-2014. 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.