FDA-Drug2016-07-27Class III

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86

Sun Pharmaceutical Industries, Inc.
Hazard

Failed Dissolution Specifications

Sold states
Nationwide
Affected count
16,085 bottles
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1446-2016

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief