D-0922-2018 Class II Terminated
FDA drug recall D-0922-2018 was initiated by La Vita Compounding Pharmacy, LLC on June 25, 2018 and is designated Class II. Reason for recall: Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. The recall status is terminated (terminated January 18, 2019). Affected quantity: 17,610 mL total dispensed in 10 mL and 30 mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2018
- Initiation Date
- June 25, 2018
- Termination Date
- January 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,610 mL total dispensed in 10 mL and 30 mL vials
Product Description
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
Reason for Recall
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Distribution Pattern
Product was distributed to patients via patient specific prescription only in CA.
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