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Azurity Pharmaceuticals, Inc. FDA Recalls
4 recalls on file across drugs, 2 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, Class IJan 4, 2024Labeling: Label Mix-up |
| Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, WoburnClass IIIDec 8, 2023Failed Impurities/Degradation Specifications: Out of specifi |
| Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) andClass IIFeb 15, 2023cGMP: complaints of crystals not redissolving into solution |
| Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.Class IAug 24, 2021Product Mix-up: Incorrect diluent component included in the |