June 2022 FDA Recall Drug by Valor Compounding Pharmacy, Inc Dba Valor Compounding Pharmacy
D-1286-2022 - Subpotent and Superpotent Drug
This Class I drug recall was voluntarily initiated by Valor Compounding Pharmacy, Inc Dba Valor Compounding Pharmacy on June 27, 2022 for the product Drug. The FDA reported the reason for recall as subpotent and superpotent drug. The product was distributed in CA only and the recall is currently terminated.
Recall Number: D-1286-2022
Subpotent and Superpotent Drug
06-27-2022
08-03-2022
5 (60 gram) tubes
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 only
09-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Batch or Lot Expiration Information
Lot# : 06162022@30, BUD 12/13/2022
