Reported Apr 12, 2023 · Terminated
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10)…
Azurity Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Azurity Pharmaceuticals, Inc. · 841 Woburn St · Wilmington, MA · 01887-3414
Is this the product you have?
- Testosterone Cypionate Injection, USP, CIII, 200 mg/mL
- packaged ina) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only
- Mfd forWilshire Pharmaceuticals, Inc., Atlanta, GA 30328
- Lot codes and dates
Lot #23804.034A23803.061AExp 9/2024
- Amount recalled
- a) 16,471 vials; b) 43,096 vials
Where it was sold
- Nationwide
Why it was recalled
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
This product could cause temporary or reversible health problems — stop using it.
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