FDA recall D-0213-2024

Product

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

USA nationwide.

Key facts

Status

Terminated

Initiation date

2023-12-08

Report date

2024-01-10

Termination date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2024