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Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 00...

FDA Recall #D-1692-2012 — Class III — July 30, 2012

Recall #D-1692-2012 Date: July 30, 2012 Classification: Class III Status: Terminated

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

Reason for Recall

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

Recalling Firm

Mallinckrodt Inc — Hazelwood, MO

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

12/2.8mCi-vials and 12/6.3mCi-vials

Distribution

AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK

Code Information

Lot 120-2686, exp. 8/2/12.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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