Recall Enforment Report D-1027-2013
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by South Coast Specialty Compounding, Inc., originally initiated on 08-23-2013 for the product Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA The product was recalled due to lack of assurance of sterility: park compounding is voluntarily recalling two lots of methylcobalamin 5mg/ml and multitrace-5 concentrate, and one lot of testosterone cypionate (sesame oil) for injection due lack of sterility assurance.. The product was distributed in Ca, In and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1027-2013 | 08-23-2013 | 09-18-2013 | Class II | 117 vials | Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA | Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance. | Terminated |
| D-1026-2013 | 08-23-2013 | 09-18-2013 | Class II | 82 vials | Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA | 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. | Terminated |
| D-1025-2013 | 08-23-2013 | 09-18-2013 | Class II | 297 vials | Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA | 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. | Terminated |
