Multi-event April 2022 FDA Recall Drug by Valor Compounding Pharmacy, Inc Dba Valor Compounding Pharmacy
This Multi-event Class I drug recall was voluntarily initiated by Valor Compounding Pharmacy, Inc Dba Valor Compounding Pharmacy on April 15, 2022 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in CA and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1167-2022
Subpotent drug
04-15-2022
06-15-2022
1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CA
11-07-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,
Batch or Lot Expiration Information
Lot# : 03312022@29, BUD: 6/10/2022
Recall Number: D-1168-2022
Subpotent drug
04-15-2022
06-15-2022
950 mLs in 1x8 oz and 2x16 oz bottles.
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CA
11-07-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Batch or Lot Expiration Information
Lot# : 04272022@35, BUD: 7/7/2022.
