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.
Reported: February 23, 2022 Initiated: February 9, 2022 #D-0558-2022
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.
Details
- Recalling Firm
- Lannett Company, Inc.
- Units Affected
- 23,598 bottles
- Distribution
- Product was distributed nationwide in the USA.
- Location
- Philadelphia, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lannett Company, Inc.. Units affected: 23,598 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 23, 2022. Severity: Moderate. Recall number: D-0558-2022.
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