Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.
D-0642-2025
Product summary
- Event
- Event 97461
- Status
- Completed
- Classification
- Class II
- Quantity
- 4,848 bottles
- Official record key
drug-enforcement:D-0642-2025
Official wording
Reason: Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Code information: Lot#: 25283185A. Expiry: 02/28/2027
Distribution pattern: OH
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet