Recalling firm
Azurity Pharmaceuticals, Inc.
Product type
Drug
Status
Terminated
Report date
2024-01-10
Distribution
USA nationwide.
Firm state
MA
Product quantity
2,220 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
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
Code / lot info
Lot #: MB22020B, Exp 12/27/2023
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.