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
Reported: April 18, 2018 Initiated: March 5, 2018 #D-0698-2018
Product Description
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
Reason for Recall
Failed impurities/degradation specifications: Failure to water content and impurity
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- 3222 vials
- Distribution
- U.S.A. nationwide
- Location
- Central Islip, NY
Frequently Asked Questions
What product 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. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 3222 vials.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Failure to water content and impurity
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 18, 2018. Severity: Low. Recall number: D-0698-2018.
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