FDA-Drug2023-05-31Class II
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Hazard
Failed Dissolution Specifications; during stability testing
Sold states
Nationwide in the U.S.A
Affected count
5,344 Bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0761-2023More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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