Drug product
Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
D-1163-2018
Product summary
- Event
- Event 80890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 vials
- Official record key
drug-enforcement:D-1163-2018
Official wording
Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Code information: Lot #: 180709/21, Exp 07-Sep-18
Distribution pattern: Nationwide in USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility