Multi-event June 2018 FDA Recall Drug by La Vita Compounding Pharmacy, Llc
This Multi-event Class II drug recall was voluntarily initiated by La Vita Compounding Pharmacy, Llc on June 25, 2018 for the product Drug. The FDA reported the reason for recall as lack of processing controls. The product was distributed in Product was distributed to patients via patient specific prescription only in CA. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0923-2018
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
06-25-2018
07-25-2018
191 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
La Vita Compounding Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to patients via patient specific prescription only in CA.
01-18-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Batch or Lot Expiration Information
Lot# : 144326@3, Exp 07/10/2018; 145953@2, Exp 08/05/2018
Recall Number: D-0922-2018
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
06-25-2018
07-25-2018
17,610 mL total dispensed in 10 mL and 30 mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
La Vita Compounding Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to patients via patient specific prescription only in CA.
01-18-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration 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
Recall Number: D-0921-2018
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
06-25-2018
07-25-2018
19,040 mL total dispensed in 10 mL and 30 mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
La Vita Compounding Pharmacy, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to patients via patient specific prescription only in CA.
01-18-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration 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
