Reported Apr 18, 2018 · Terminated

Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for:…

InvaGen Pharmaceuticals, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: InvaGen Pharmaceuticals, Inc. · 550 S Research Pl · Central Islip, NY · 11722-4415

Is this the product you have?

  • Decitabine for Injection, 50mg per vial, Rx only
  • Manufactured byCipla Ltd., Verna Goa, India
  • Manufactured forCipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
Lot codes and dates
    • Lot #: GE70493
    • GE70502
    • GE70512
    • Exp 8/2019
Amount recalled
3222 vials

Where it was sold

  • Nationwide

Why it was recalled

Failed impurities/degradation specifications: Failure to water content and impurity

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 20, 2021 · Data as of Sep 19, 7:18 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.