D-0558-2022 Class II Terminated
FDA drug recall D-0558-2022 was initiated by Lannett Company, Inc. on February 9, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification results for related substances. The recall status is terminated (terminated May 1, 2023). Affected quantity: 23,598 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 23, 2022
- Initiation Date
- February 9, 2022
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,598 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Distribution Pattern
Product was distributed nationwide in the USA.
Code Information
Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023