D-0921-2018 Class II Terminated
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
- 19,040 mL total dispensed in 10 mL and 30 mL vials
Product Description
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
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 #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