Azurity Pharmaceuticals, Inc. recalls Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Wobur…
- Recall date
- December 8, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0213-2024
- FDA classification
- Class III
- Brand / firm
- Azurity Pharmaceuticals, Inc.
- Sold / distributed
- USA nationwide.
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.
Class III means the product violates regulations but is not likely to cause harm.
What 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
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