FDA Drug recall D-1442-2012
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
- FDA Drug
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 by Teva Pharmaceuticals Usa, citing presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1442-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-18 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Reason
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Identifiers
| ndc | 68546-317-00 |
|---|---|
| ndc | 68546-317-30 |
| ndc | 68546-325-06 |
| ndc | 68546-325-12 |
| code_info | Lot number X05011, Exp 08/13 |
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-1442-2012%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.