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SafetyAlerts
September 28, 2001

CIS-US, Inc. Recalls Pulmolite Kit

Bedford, MA(SafetyAlerts) - The Food and Drug Administration (FDA) said that CIS-US, Inc. is recalling Pulmolite, a kit for the preparation of Technetium Tc99m Albumin Aggregated for Injection, labeled as sterile and non-pyrogenic, Rx, for diagnostic use.

This is the first public notice of this Class lI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-305-1, Pulmolite, a kit for the preparation of Technetium Tc99m Albumin Aggregated for Injection, labeled as sterile and non-pyrogenic, Rx, for diagnostic use.

Codes:
Lot Number 127254; Expiration Date 01 AUG 02.

REASON:
Lack of assurance of sterility (crimp seal problems).

MANUFACTURER:
Ben Venue Laboratories, Inc. Bedford, OH.

RECALLED BY:
CIS-US, Inc., Bedford, MA, by letter on 7/27/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
33,475 vials.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.