D-1027-2013 Class II Terminated
FDA drug recall D-1027-2013 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 voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injec… The recall status is terminated (terminated October 17, 2013). Affected quantity: 117 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
- 117 vials
Product Description
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
Reason for Recall
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.
Distribution Pattern
CA, IN
Code Information
Lot #05072013@1, Exp 11/3/2013