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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: GE70493, GE70502, GE70512, Exp 8/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- InvaGen Pharmaceuticals, Inc.
- Reason for Recall:
- Failed impurities/degradation specifications: Failure to water content and impurity
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot #: GE70493, GE70502, GE70512, Exp 8/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0698-2018
Related Recalls
Defective Container: powder may leak out of the pouch
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Defective Container; actuator may improperly function and affect dose delivery.