Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 9470
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Summary
The FDA issued a Class I for Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy by Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy. Reason: Subpotent and Superpotent Drug.
Details
Source
Drug Recall
External ID
D-1286-2022
Action Date
2022-08-03
Status
Terminated
Category
drug
Product Description
Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Lot/Code Info: Lot #: 06162022@30, BUD 12/13/2022
Quantity Affected: 5 (60 gram) tubes
Reason for Recall
Subpotent and Superpotent Drug
Distribution
CA only
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-27
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 77 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy have FDA actions?
Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1286-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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