Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Reported: January 10, 2024 Initiated: December 8, 2023 #D-0213-2024
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.
Details
- Recalling Firm
- Azurity Pharmaceuticals, Inc.
- Units Affected
- 2,220 bottles
- Distribution
- USA nationwide.
- Location
- Wilmington, MA
Frequently Asked Questions
What product was recalled? ▼
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1. Recalled by Azurity Pharmaceuticals, Inc.. Units affected: 2,220 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 10, 2024. Severity: Low. Recall number: D-0213-2024.
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