FDA-Drug2017-02-01Class III
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) 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
Sun Pharmaceutical Industries, Inc.
Hazard
Failed Dissolution Specifications; 18 month stability time point
Sold states
Nationwide
Affected count
a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2017Don't want to check this manually?
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