Copaxone 20 mg Injection PFS — Class II drug recall D-0766-2018
Terminated recall by Kroger Specialty Pharmacy, Inc., reported 2018-05-16, distributed in AR, FL, IL, LA, MS. Lack of Processing Controls.
| Recall number | D-0766-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kroger Specialty Pharmacy, Inc., Vicksburg, MS, United States |
| Recall initiated | 2018-04-03 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-05-07 |
| Distributed | AR, FL, IL, LA, MS |
| NDC | 68546-0317-30 |
Product
Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
Reason for recall
Lack of Processing Controls.
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-0766-2018. 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.