Status
Terminated
Drug Enforcement D-0213-2024
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Classification
Class III
Report Date
January 10, 2024
Termination Date
April 24, 2024
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide.
Location & Firm
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Address
-
841 Woburn St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0213-2024
- Event ID
- 93552
- Recall initiation date
- December 8, 2023
- Center classification date
- January 2, 2024
- Code info
- Lot #: MB22020B, Exp 12/27/2023
- More code info
- —