March 2018 FDA Recall Drug by Invagen Pharmaceuticals, Inc.
D-0698-2018 - Failed impurities/degradation specifications

This Class III drug recall was voluntarily initiated by Invagen Pharmaceuticals, Inc. on March 5, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0698-2018

Reason for Recall
Failed impurities/degradation specifications: Failure to water content and impurity
Initiated
03-05-2018
Reported
04-18-2018
Quantity
3222 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79729
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-20-2021
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : GE70493, GE70502, GE70512, Exp 8/2019