FDA Drug recall D-1445-2014
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx o…
- FDA Drug
- Class III
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class III recall of Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx o… by Sandoz, citing failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1445-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-11 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Identifiers
| ndc | 0185-0022-10 |
|---|---|
| ndc | 0185-0022-01 |
| code_info | Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16 |
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-1445-2014%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.