buPROPrion Hydrochloride Extended-Release Tablets…

Date

May 31, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

Product

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

Reason

Failed Dissolution Specifications; during stability testing

Distribution pattern

Nationwide in the U.S.A

Quantity

5,344 Bottles

Codes and lots

Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023

Recall started

May 9, 2023

Recall number

D-0761-2023

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0761-2023. The agency record governs; check it and the company before acting.