Recalls / Class III

Class IIID-0446-2017

Product

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86

Affected lot / code info

JKP0905A 04/17

Why it was recalled

Failed Dissolution Specifications; 18 month stability time point

Recalling firm

Firm

Sun Pharmaceutical Industries, Inc.

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605

Distribution

Quantity

11,618 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-12-20

FDA classified

2017-01-25

Posted by FDA

2017-02-01

Terminated

2018-07-11

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0446-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.