Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn
Summary
The FDA issued a Class III for Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactu by Azurity Pharmaceuticals, Inc.. Reason: Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stabil.
Details
Source
Drug Recall
External ID
D-0213-2024
Action Date
2024-01-10
Status
Terminated
Category
drug
Product Description
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Lot/Code Info: Lot #: MB22020B, Exp 12/27/2023
Quantity Affected: 2,220 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-08
Company
Wilmington, MA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 72 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Azurity Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Azurity Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Azurity Pharmaceuticals, Inc. have FDA actions?
Azurity Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0213-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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