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Recall Observatory FDA recall evidence

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

June 25, 2018

Class II

Product summary

Firm
La Vita Compounding Pharmacy, LLC
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

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls