Azurity Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and
Recalled April 12, 2023 · FDA recall D-0489-2023 · Azurity Pharmaceuticals
Hazard
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. · FDA Class II
Units
a) 16,471 vials; b) 43,096 vials
Sold at
US Nationwide
Description
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Product
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.
Manufacturer(s)
Azurity Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →