Recalls / Class II
Class IID-1025-2013
Product
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
- Affected lot / code info
- Lot #06132013@1, Exp 12/10/2013
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.
Recalling firm
- Firm
- South Coast Specialty Compounding, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 9257 Research Dr, N/A, Irvine, California 92618-4286
Distribution
- Quantity
- 297 vials
- Distribution pattern
- CA, IN
Timeline
- Recall initiated
- 2013-08-23
- FDA classified
- 2013-09-12
- Posted by FDA
- 2013-09-18
- Terminated
- 2013-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1025-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.