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.
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 numbers, UPCs & expiration codes
Lot #: MB22020B, Exp 12/27/2023
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0213-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 8, 2023
- FDA report date
- Jan 10, 2024
- Quantity
- 2,220 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Azurity Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0213-2024, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 93552
- Address
- 841 Woburn St
- Code information
- Lot #: MB22020B, Exp 12/27/2023
- Postal code
- 01887-3414
- Report date
- Jan 10, 2024
- Product type
- Drugs
- Recall number
- D-0213-2024
- Classification
- Class III
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Product quantity
- 2,220 bottles
- Termination date
- Apr 24, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Dec 8, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2024