FDA-Drug2016-10-12Class III

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86

Sun Pharmaceutical Industries, Inc.
Hazard

Failed Dissolution Specifications

Sold states
Nationwide
Affected count
31,762 bottles
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2017

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