Home / Recalls / Azurity Pharmaceuticals, Inc. / D-0489-2023

D-0489-2023 Class II Terminated

Recalled by Azurity Pharmaceuticals, Inc. — Wilmington, MA

FDA drug recall D-0489-2023 was initiated by Azurity Pharmaceuticals, Inc. on Feb 15, 2023 and is designated Class II. Reason for recall: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. The recall status is terminated (terminated Dec 4, 2023). Affected quantity: a) 16,471 vials; b) 43,096 vials.

Recall details

Product Type: Drugs
Report Date: Apr 12, 2023
Initiation Date: Feb 15, 2023
Termination Date: Dec 4, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 16,471 vials; b) 43,096 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.

Reason for recall

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

Distribution pattern

US Nationwide

Code information

Lot #23804.034A, 23803.061A, Exp 9/2024

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0489-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.