Azurity Pharmaceuticals recalls
FDA enforcement reports naming Azurity Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 2
- Most recent report
- Feb 7, 2024
- Feb 7, 2024Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, MfdDrug · Azurity Pharmaceuticals, Inc.Labeling: Label Mix-upClass I
- Jan 10, 2024Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for…Drug · Azurity Pharmaceuticals, Inc.Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.Class III
- Apr 12, 2023Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-…Drug · Azurity Pharmaceuticals, Inc.cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.Class II
- Oct 13, 2021Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit…Drug · Azurity Pharmaceuticals, Inc.Product Mix-up: Incorrect diluent component included in the kit.Class I