Reported Jan 22, 2020 · Terminated

Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx…

Sun Pharmaceutical Industries, 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: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605

Is this the product you have?

  • Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only
  • Distributed bySun Pharmaceuticals, Inc., Cranbury, NJ
  • Manufactured bySun Pharmaceuticals, Industries, Ltd., Gujarat, India
Lot codes and dates

6 of 6 products

Products covered by this recall
#Product as published
1JKT0933A, JKT0935A, JKT1062A exp Mar-20
2JKT1425A, JKT1483A exp Apr-20
3JKT1575A, JKT1729A, JKT1730A, JKT1728A exp May-20 JKT2002A exp Jun-20
4JKT3216A, JKT3217A exp Sep-20
5JKT3589A, JKT3590A, JKT3626A exp Oct-20
6JKT3864A, JKT3935A exp Dec-20

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Why it was recalled

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

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 Aug 31, 2020 · Data as of Sep 19, 7:15 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.