D-0137-2024 Class III Terminated

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
December 13, 2023
Initiation Date
November 22, 2023
Termination Date
June 27, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2016 Bottles

Product Description

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

Distribution Pattern

Nationwide

Code Information

Lot HAD0630A, exp 1/2024