D-0268-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 15, 2023
- Initiation Date
- January 31, 2023
- Termination Date
- June 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3665 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025