Drug recall D-0137-2024

Class III Terminated reported Dec 13, 2023

Product

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86

Reason for recall

Failed Dissolution Specifications

Lots and codes

Lot HAD0630A, exp 1/2024

Recall details

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Quantity
2016 Bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 22, 2023
Terminated
June 27, 2024

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