Why it was recalled
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 2090-190841, Exp 3/30/3019
Where it was sold
Nationwide in the USA
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-1134-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 26, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 110 10 ml vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medi-Physics Inc. dba GE Healthcare
Original FDA data
Every field from FDA enforcement report D-1134-2019, exactly as published.
Show all FDA fields
- City
- Arlington Heights
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82567
- Address
- 3350 N Ridge Ave
- Code information
- Lot: 2090-190841, Exp 3/30/3019
- Postal code
- 60004-1412
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1134-2019
- Classification
- Class III
- Recalling firm
- Medi-Physics Inc. dba GE Healthcare
- Product quantity
- 110 10 ml vials
- Termination date
- Nov 6, 2020
- Reason for recall
- Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 26, 2019
- Initial firm notification
- Telephone
- Center classification date
- Apr 16, 2019