Posaconazole Antifungal Tablets Recalled for Degradation Impurities
Biocon Pharma Inc. is recalling Posaconazole Delayed-Release Tablets due to failed degradation specifications and out-of-specification impurities that may compromise medication safety and efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prescription antifungal medication due to failed impurity and degradation specifications. The rubric classifies this as high severity: a risk-of-harm product where no illnesses or injuries have been reported, warranting precautionary action.
Plain-English summary
Biocon Pharma Inc. is recalling Posaconazole Delayed-Release Tablets, 100 mg, distributed nationwide in the United States. The recall affects approximately 3,665 bottles.
The tablets failed quality control testing for degradation specifications. Testing revealed out-of-specification degradation results and impurities exceeding acceptable limits. The affected lots are BF21003163, BF21003246, BF21003161 (expiring September 2023), BF21004742 (expiring December 2023), and BF22003359 (expiring September 2025).
This prescription antifungal medication is used to prevent or treat serious fungal infections. Patients taking this medication should contact their healthcare provider or pharmacist immediately to determine if their supply may be affected and discuss appropriate treatment options.
Patients should not discontinue their medication without consulting a healthcare provider. Those with concerns should contact their healthcare provider immediately. Healthcare providers and pharmacies should stop dispensing the affected lots and quarantine remaining stock.
The recalled product
- Product
- POSACONAZOLE (POSACONAZOLE)
- Brand
- POSACONAZOLE
- Manufacturer
- BIOCON PHARMA INC
- Category
- Drug — Prescription Antifungal
- Hazard
- impurity
- degradation
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 (8)
- Lot #: BF21003163
- BF21003246
- BF21003161
- Exp. Sep-2023
- BF21004742
- Exp. Dec-2023
- BF22003359
- Exp. Sep-2025
Distribution
Distributed nationwide across the United States.
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