Drug recall D-0268-2023

Class II Terminated reported Feb 15, 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.

Reason for recall

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Lots and codes

Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025

Recall details

Recalling firm
BIOCON PHARMA INC, ISELIN, NJ
Quantity
3665 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2023
Terminated
June 21, 2024

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