Drug product
Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
D-1160-2018
Product summary
- Event
- Event 80890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114 vials
- Official record key
drug-enforcement:D-1160-2018
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 #: a) 180618/2, Exp 16-Sep-18; b) 180618/2, Exp 16-Sep-18
Distribution pattern: Nationwide in USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility