FDAFDA · Food and drugs·Recall number D-0489-2023
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.
Published April 12, 2023 · Recall initiated: February 15, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Distributor
- US Nationwide
- Lot
- Lot #23804.034A, 23803.061A, Exp 9/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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