Nifedipine WSP Ointment Recalled Due to Potency Variability
Valor Compounding Pharmacy is recalling Nifedipine WSP 0.2% Ointment due to potency variability. Some batches may be subpotent or superpotent, affecting safety and efficacy.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. Although no deaths or reported illnesses have been documented, the potency variability—creating risks of both therapeutic failure (subpotent) and potential overdose (superpotent)—warrants the Severe classification.
Plain-English summary
Valor Compounding Pharmacy is recalling Nifedipine WSP 0.2% Ointment in 60-gram tubes (Lot #06162022@30, Beyond Use Date 12/13/2022) distributed in California. The U.S. Food and Drug Administration issued this Class I recall.
The ointment contains potency variability, with some batches found to be subpotent (below-strength) and others superpotent (above-strength). This inconsistency affects both the safety and efficacy of the medication.
Patients in California who have received this ointment should discontinue use immediately and contact their healthcare provider or pharmacist for guidance. Do not use any remaining product from the affected lot. Consult with your prescribing physician if you have questions.
The recalled product
- Product
- Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 06162022@30
- BUD 12/13/2022
Distribution
Distributed in 1 state:
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