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

FDA recall notice · announced April 18, 2018 · Invagen Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: U.S.A. nationwide
Lot/code information: Lot #: GE70493, GE70502, GE70512, Exp 8/2019
Quantity: 3222 vials
Status: Terminated
Products in this recall event:
- 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 6 (D-0698-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.