D-0213-2024 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2024
- Initiation Date
- December 8, 2023
- Termination Date
- April 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,220 bottles
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
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 Pattern
USA nationwide.
Code Information
Lot #: MB22020B, Exp 12/27/2023