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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, Kit for the preparation of Technetium Tc99m Albumin Aggregated for Injection Sterile and non-pyrogenic Lot 127254; Exp. Date: 01 AUG 02 For Diagnostic Use Rx Only NDA 17-776.

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

RECALL NUMBER, PRODUCT AND CODE:
D-305-1 Pulmolite, Kit for the preparation of Technetium Tc99m Albumin Aggregated forInjection Sterile and non-pyrogenic Lot 127254; Exp. Date: 01 AUG 02 For Diagnostic Use Rx Only NDA 17-776

Codes:
Pulmolite, Lot 127254. Exp. Date: 01 AUG 02

REASON:
Lack of assurance of sterility(Crimp seal problems)

MANUFACTURER/RECALLING FIRM:
Ben Venue Laboratories, Inc. Bedford, OH.

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

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
33,475 vials packaged in 5 vial kits and 30 vial kits.

 
Selected Recent Recalls


Health Professional:

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

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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.