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 #: GE70493GE70502GE70512Exp 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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