FDA-Drug2023-04-12Class II
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.
Azurity Pharmaceuticals, Inc.
Hazard
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Sold states
US Nationwide
Affected count
a) 16,471 vials; b) 43,096 vials
Manufactured in
841 Woburn St, Wilmington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief