Copaxone — Class II drug recall D-001-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2013-11-27, distributed nationwide. Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consum
| Recall number | D-001-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2013-10-24 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 6,803 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00368546317304 |
| NDC | 68546-0317, 68546-0317-00, 68546-0317-30, 68546-0325, 68546-0325-06, 68546-0325-12 |
| Lot numbers | 10/14, X06381 |
Product
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.
Reason for recall
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
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-001-2014. 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.