Drug product
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
D-0922-2018
Product summary
- Event
- Event 80416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,610 mL total dispensed in 10 mL and 30 mL vials
- Official record key
drug-enforcement:D-0922-2018
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 #: 140089@1, Exp 08/06/2018; 141968@6, Exp 09/03/2018; 143381@2, Exp 09/24/2018; 145265@13, Exp 10/22/2018; 146479@6, Exp 11/12/2018
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