Recalls / Class II
Class IID-0558-2022
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.
- Affected lot / code info
- Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Recalling firm
- Firm
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9000 State Rd, N/A, Philadelphia, Pennsylvania 19136-1615
Distribution
- Quantity
- 23,598 bottles
- Distribution pattern
- Product was distributed nationwide in the USA.
Timeline
- Recall initiated
- 2022-02-09
- FDA classified
- 2022-02-14
- Posted by FDA
- 2022-02-23
- Terminated
- 2023-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0558-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.