Why it was recalled
Failed impurities/degradation specifications: Failure to water content and impurity
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
Lot numbers, UPCs & expiration codes
Lot #: GE70493, GE70502, GE70512, Exp 8/2019
Where it was sold
U.S.A. nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0698-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 5, 2018
- FDA report date
- Apr 18, 2018
- Quantity
- 3222 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0698-2018, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 79729
- Address
- 550 S Research Pl
- Code information
- Lot #: GE70493, GE70502, GE70512, Exp 8/2019
- Postal code
- 11722-4415
- Report date
- Apr 18, 2018
- Product type
- Drugs
- Recall number
- D-0698-2018
- Classification
- Class III
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 3222 vials
- Termination date
- Jan 20, 2021
- Reason for recall
- Failed impurities/degradation specifications: Failure to water content and impurity
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. nationwide
- Recall initiation date
- Mar 5, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 26, 2018