FDA recall D-0489-2023

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.

Reason for recall

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

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2023-02-15

Report date

2023-04-12

Termination date

2023-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2023