Azurity Pharmaceuticals, Inc.

4 FDA enforcement actions

4 Total Recalls

2 Class I

1 Class II

1 Class III

Firm Details

Product Types: drug
States: MA

All Recalls

Class I: Dangerous 01/04/2024 drug

Labeling: Label Mix-up
Class III: Low Risk 12/08/2023 drug

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II: Risk 02/15/2023 drug

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class I: Dangerous 08/24/2021 drug

Product Mix-up: Incorrect diluent component included in the kit.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.