InvaGen Pharmaceuticals, Inc. recalls Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipl…
- Recall date
- March 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0698-2018
- FDA classification
- Class III
- Brand / firm
- InvaGen Pharmaceuticals, Inc.
- Sold / distributed
- U.S.A. nationwide
Why it was recalled
Failed impurities/degradation specifications: Failure to water content and impurity
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
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