FDA-Drug2025-10-01Class III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Hazard
Failed Impurities/Degradation Specifications:
Sold states
Distributed Nationwide in the USA
Affected count
9,917 bottles
Manufactured in
3701 Concorde Pkwy, N/A, Chantilly, VA, United States
Products
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0671-2025Want us to check the next one for you?
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