FDAClass IIIApril 18, 2018

Decitabine for Injection recall: Impurity Out of Spec

Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass…

Why was Decitabine for Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: GE70493, GE70502, GE70512, Exp 8/2019

Product
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass…
Recalling firm
InvaGen Pharmaceuticals, Inc.
Quantity
3222 vials
Distribution
U.S.A. nationwide
Recall date
April 18, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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