FDA-Drug2023-12-13Class III
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Hazard
Failed Dissolution Specifications
Sold states
Nationwide
Affected count
2016 Bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0137-2024More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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