Bupropion Hydrochloride Extended-Release Tablets USP (SR)…

Date

Oct. 25, 2023

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

Product

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

Failed Dissolution Specifications

Distribution pattern

Nationwide in the USA.

Quantity

144 bottles

Codes and lots

Lot #: HAD0360A, Exp. 12/2023

Recall started

Oct. 4, 2023

Recall number

D-0044-2024

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0044-2024. The agency record governs; check it and the company before acting.