D-1025-2013 Class II Terminated
FDA drug recall D-1025-2013 was initiated by South Coast Specialty Compounding, Inc. on August 23, 2013 and is designated Class II. 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 assuranc… The recall status is terminated (terminated October 17, 2013). Affected quantity: 297 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2013
- Initiation Date
- August 23, 2013
- Termination Date
- October 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 297 vials
Product Description
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.
Distribution Pattern
CA, IN
Code Information
Lot #06132013@1, Exp 12/10/2013