FDA-Drug2023-10-25Class III

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA.
Affected count
144 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0044-2024

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