Status
Terminated
Drug Enforcement D-1025-2013
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.
Classification
Class II
Report Date
September 18, 2013
Termination Date
October 17, 2013
Product Information
- Product description
- Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
- Product quantity
- 297 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- CA, IN
Location & Firm
- Recalling firm
- South Coast Specialty Compounding, Inc.
- Address
-
9257 Research Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1025-2013
- Event ID
- 66083
- Recall initiation date
- August 23, 2013
- Center classification date
- September 12, 2013
- Code info
- Lot #06132013@1, Exp 12/10/2013
- More code info
- —