Recalls / Class III
Class IIID-0213-2024
Product
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
- Brand name
- Eprontia
- Generic name
- Topiramate
- Active ingredient
- Topiramate
- Route
- Oral
- NDC
- 52652-9001
- FDA application
- NDA214679
- Affected lot / code info
- Lot #: MB22020B, Exp 12/27/2023
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.
Recalling firm
- Firm
- Azurity Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 841 Woburn St, N/A, Wilmington, Massachusetts 01887-3414
Distribution
- Quantity
- 2,220 bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2023-12-08
- FDA classified
- 2024-01-02
- Posted by FDA
- 2024-01-10
- Terminated
- 2024-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0213-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.