D-0137-2024Class III

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm

Product type

Drug

Status

Terminated

Report date

2023-12-13

Distribution

Nationwide

Firm state

Product quantity

2016 Bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Failed Dissolution Specifications

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

Code / lot info

Lot HAD0630A, exp 1/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.