Why it was recalled
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Product description
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134
Lot numbers, UPCs & expiration codes
Lot 120-2686, exp. 8/2/12.
Where it was sold
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
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-1692-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 30, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 12/2.8mCi-vials and 12/6.3mCi-vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mallinckrodt Inc
Original FDA data
Every field from FDA enforcement report D-1692-2012, exactly as published.
Show all FDA fields
- City
- Hazelwood
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 62696
- Address
- 675 James S McDonnell Blvd
- Code information
- Lot 120-2686, exp. 8/2/12.
- Postal code
- 63042-2301
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1692-2012
- Classification
- Class III
- Recalling firm
- Mallinckrodt Inc
- Product quantity
- 12/2.8mCi-vials and 12/6.3mCi-vials
- Termination date
- Nov 16, 2012
- Reason for recall
- Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134
- Distribution pattern
- AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
- Recall initiation date
- Jul 30, 2012
- Initial firm notification
- FAX
- Center classification date
- Sep 25, 2012