US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 23, 2013 (13 years ago)

Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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.

What was recalled

Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA

Recalling firm
South Coast Specialty Compounding, Inc.
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1025-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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