FDA-Drug2025-10-29Class II
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Graviti Pharmaceuticals Private Limited
Hazard
Failed Tablet/Capsule Specifications
Sold states
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Affected count
46,512/30 count bottles
Manufactured in
E & 621 Patancheru Mandal, Isnapur Village Rd; Survey No 621, Hyderabad, India
Products
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0037-2026Don't want to check this manually?
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