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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Manufacturer
- Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
- Hazard
- sub-potency
- super-potency
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:
- CA
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