FDA-Drug2024-01-10Class III
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Azurity Pharmaceuticals, Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Sold states
USA nationwide.
Affected count
2,220 bottles
Manufactured in
841 Woburn St, N/A, Wilmington, MA, United States
Products
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief