Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lanne
Summary
The FDA issued a Class II for Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and by Lannett Company, Inc.. Reason: Failed Impurities/Degradation Specifications: Out of specification results for related substances..
Details
Source
Drug Recall
External ID
D-0558-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
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/Code Info: Lot #: 2664A, 2664B, Exp. date 07/2022; 2874A, 2874B, Exp. date 01/2023
Quantity Affected: 23,598 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Distribution
Product was distributed nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-09
Company
Philadelphia, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lannett Company, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lannett Company, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lannett Company, Inc. have FDA actions?
Lannett Company, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0558-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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