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.

Recall Number: D-0489-2023

Firm: Azurity Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230412

Initiation Date: 20230215

Termination Date: 20231204

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

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.