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 #23804.034A
    • 23803.061A
    • Exp 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 4, 2023 · Data as of Sep 19, 8:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.