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SafetyAlerts
November 19,  2003

Mallinckrodt Has Recalled Products

(SafetyAlerts) - The FDA has released the following information.

 

PRODUCT
a) Entrobar Barium Sulfate Suspension, Rx Only, (50% w/v
barium sulfate USP suspension), Net Contents: 500 ml,
Recall # D-054-4;
b) Entrocel, Methylcellulose solution, (1.8% w/v
hydroxpropyl methylcellulose solution...), For
Professional Use Only, Net Contents: 500 ml.
Recall # D-055-4;
c) Entrokit Enteroclysis Kit,(This kit contains both
Entrobar and Entrocel product). Recall # D-056-4;
d) Entrokit Enteroclysis Kit with Catheter.
Recall # D-057-4.

CODE
a) Lot 21265, exp 12/31/2005;
b) Lot 21009, Exp 10/31/2005; Lot 21112, Exp 11/30/2005;
Lot 21140, Exp11/30/2005.
c) Lot 30179, exp 12/31/2003; Lot 30442, exp 03/31/2004;
d) Lot 30179, exp 12/31/2003; Lot 30422, exp 03/31/2004;
Lot 30494, exp 03/31/2004.

RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc, Hazelwood, MO, by letter on October 2, 2003. Firm initiated recall is ongoing.

REASON
Mislabeling: Entrobar labeled bottles may contain Entrocel (clear liquid) or Entrocel labeled bottles may contain Entrobar (milky-white liquid).

VOLUME OF PRODUCT IN COMMERCE
906 cases (12 units/case).

DISTRIBUTION
Nationwide.

 
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.