D-0044-2024Class III

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm

Product type

Drug

Status

Terminated

Report date

2023-10-25

Distribution

Nationwide in the USA.

Firm state

Product quantity

144 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), 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

Code / lot info

Lot #: HAD0360A, Exp. 12/2023

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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.