Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
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.
Lot numbers, UPCs & expiration codes
Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
Where it was sold
Product was distributed nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0558-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 23,598 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company, Inc.
Original FDA data
Every field from FDA enforcement report D-0558-2022, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 89551
- Address
- 9000 State Rd
- Code information
- Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
- Postal code
- 19136-1615
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0558-2022
- Classification
- Class II
- Recalling firm
- Lannett Company, Inc.
- Product quantity
- 23,598 bottles
- Termination date
- May 1, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results for related substances.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed nationwide in the USA.
- Recall initiation date
- Feb 9, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 14, 2022