Diazepam Oral Solution recall: Impurity Out of Spec
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.
Why was Diazepam Oral Solution recalled?
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
- 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.
- Recalling firm
- Lannett Company, Inc.
- Quantity
- 23,598 bottles
- Distribution
- Product was distributed nationwide in the USA.
- Recall date
- February 23, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)