Drug product
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
D-0671-2025
Product summary
- Event
- Event 97504
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 9,917 bottles
- Official record key
drug-enforcement:D-0671-2025
Official wording
Reason: Failed Impurities/Degradation Specifications:
Code information: Lot#: GPC250178A, Exp Date: 06-22-2027
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications