Reported Jan 10, 2024 · Terminated
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals,…
Azurity Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Azurity Pharmaceuticals, Inc. · 841 Woburn St · Wilmington, MA · 01887-3414
Is this the product you have?
- Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only
- Manufactured forAzurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
- Lot codes and dates
Lot #: MB22020BExp 12/27/2023
- Amount recalled
- 2,220 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Azurity Pharmaceuticals, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.