Diazepam Oral Solution Recalled for Failed Impurity Specifications
Lannett Company is recalling Diazepam Oral Solution (Concentrate) 5 mg/mL due to out-of-specification results for related substances, indicating failed impurities and degradation testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a drug quality defect (failed impurity/degradation specifications). No illnesses or injuries are reported in the source text. Per the rubric, Class II recalls with no reported hospitalization or injury are typically scored as 2 (Moderate).
Plain-English summary
Lannett Company, Inc. is recalling Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), in 30 mL bottles with dropper, NDC 0527-1768-36. The recall affects approximately 23,598 bottles that were distributed nationwide in the USA.
The recall was initiated because testing identified out-of-specification results for related substances, indicating that the product failed impurities and degradation specifications.
Affected lots are: Lot #2664A, Lot #2664B (expiration date 07/2022), and Lot #2874A, Lot #2874B (expiration date 01/2023).
Patients taking this medication should consult their healthcare provider or pharmacist about the recall. Individuals with questions may contact Lannett Company, Inc.
The recalled product
- 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.
- Manufacturer
- Lannett Company, Inc.
- Hazard
- impurity-degradation
- out-of-specification
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 2664A
- 2664B
- Exp. date 07/2022
- 2874A
- 2874B
- Exp. date 01/2023
Distribution
Distributed nationwide across the United States.
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