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.

FDA recall notice · announced April 12, 2023 · Azurity Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: US Nationwide
Lot/code information: Lot #23804.034A, 23803.061A, Exp 9/2024
Quantity: a) 16,471 vials; b) 43,096 vials
Status: Terminated
Products in this recall event:
- 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 Pharma (D-0489-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.