Drug product
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
D-0921-2018
Product summary
- Event
- Event 80416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,040 mL total dispensed in 10 mL and 30 mL vials
- Official record key
drug-enforcement:D-0921-2018
Official wording
Reason: Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Code information: Lot #s: 139140@3, Exp 07/23/2018; 141106@1, Exp 08/21/2018; 142919@13, Exp 09/17/2018; 143291@6, Exp 09/23/2018; 145701@3, Exp 10/29/2018; 146932@3, Exp 11/19/2018
Distribution pattern: Product was distributed to patients via patient specific prescription only in CA.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls