July 2012 FDA Recall Drug by Mallinckrodt Inc
D-1692-2012 - Labeling

This Class III drug recall was voluntarily initiated by Mallinckrodt Inc on July 30, 2012 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK and the recall is currently terminated.

Recall Number: D-1692-2012

Reason for Recall
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Initiated
07-30-2012
Reported
10-03-2012
Quantity
12/2.8mCi-vials and 12/6.3mCi-vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62696
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.
Mallinckrodt 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.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-16-2012
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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