D-0044-2024 Class III Terminated

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
October 25, 2023
Initiation Date
October 4, 2023
Termination Date
February 2, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
144 bottles

Product Description

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: HAD0360A, Exp. 12/2023