Drug product
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
D-0558-2022
Product summary
- Event
- Event 89551
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,598 bottles
- Official record key
drug-enforcement:D-0558-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Code information: Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
Distribution pattern: Product was distributed nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of specification