Methylcobalamin Injection 5 mg/mL — Class II drug recall D-1025-2013
Terminated recall by South Coast Specialty Compounding, Inc., reported 2013-09-18, distributed in CA, IN. Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrat
| Recall number | D-1025-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | South Coast Specialty Compounding, Inc., Irvine, CA, United States |
| Recall initiated | 2013-08-23 |
| Classified | 2013-09-12 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2013-10-17 |
| Distributed | CA, IN |
| Quantity | 297 vials |
| Reason classes | sterility |
| Expiration dates | 2013-12-10 |
Product
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Reason for recall
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
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-1025-2013. 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.