March 2019 FDA Recall Drug by Medi-physics Inc. Dba Ge Healthcare
D-1134-2019 - Chemical Contamination
This Class III drug recall was voluntarily initiated by Medi-physics Inc. Dba Ge Healthcare on March 26, 2019 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1134-2019
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
03-26-2019
04-17-2019
110 10 ml vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medi-Physics Inc. dba GE Healthcare
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-06-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18
Batch or Lot Expiration Information
Lot# Lot: 2090-190841, Exp 3/30/3019
