Azurity Pharmaceuticals, Inc.: Drug Recall

Recall #D-0489-2023 · 02/15/2023

Class II: Risk

Recall Details

Recall Number: D-0489-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Azurity Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 02/15/2023
Location: Wilmington, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 16,471 vials; b) 43,096 vials

Reason for Recall

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Product Description

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

Distribution Pattern

US Nationwide

Other Recalls by Azurity Pharmaceuticals, Inc.

Class I: Dangerous 01/04/2024

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

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class I: Dangerous 08/24/2021

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

View all recalls by Azurity Pharmaceuticals, Inc. →

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.