FDAFDA · Food and drugs·Recall number D-0268-2023
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
Published February 15, 2023 · Recall initiated: January 31, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- POSACONAZOLE
- Manufacturer
- BIOCON PHARMA INC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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