METHYLCOBALAMIN * 10 mg/mL INJECTABLE — Class II drug recall D-431-2014
Terminated recall by Specialty Medicine Compounding Pharmacy, reported 2014-01-22, distributed in MI. Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recal
| Recall number | D-431-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Specialty Medicine Compounding Pharmacy, South Lyon, MI, United States |
| Recall initiated | 2013-10-19 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-09-22 |
| Distributed | MI |
| Quantity | 726.45 ml |
| Reason classes | sterility |
Product
METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reason for recall
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
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-431-2014. 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.