Recalls / Class II
Class IID-0268-2023
Product
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.
- Brand name
- Posaconazole
- Generic name
- Posaconazole
- Active ingredient
- Posaconazole
- Route
- Oral
- NDC
- 70377-038
- FDA application
- ANDA214476
- Affected lot / code info
- Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Why it was recalled
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Recalling firm
- Firm
- BIOCON PHARMA INC
- Manufacturer
- Biocon Phama Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 485 HWY 1 (S), ISELIN, New Jersey 08830
Distribution
- Quantity
- 3665 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-01-31
- FDA classified
- 2023-02-14
- Posted by FDA
- 2023-02-15
- Terminated
- 2024-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0268-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.