FDA-Drug2025-07-09Class II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Granules Pharmaceuticals Inc.
Hazard
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Sold states
Nationwide in the USA.
Affected count
27,648 100-count Bottles; 5,376 500-count Bottles
Manufactured in
3701 Concorde Pkwy, Chantilly, VA, United States
Products
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2025Don't want to check this manually?
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