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SafetyAlerts
May 23, 2002

B. Braun Medical Has Recalled FreAmine III (Amino Acid)

Irvine, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said that B. Braun Medical, Inc. has recalled 8.5% FreAmine III (Amino Acid) Injection, 1000 mL glass intravenous infusion bottles, Rx only. Recall # D-261-2; and 10% FreAmine III (Amino Acid) Injection, 1000 mL glass intravenous infusion bottles, Rx only. Recall # D-262-2

PRODUCT
VERSED Syrup (midazolam HCl) CIV, 118 ml (2mg/mL) bottles, Rx only. Recall # D-263-2.

CODE
Lot U0009-50 exp. 4/2003
Lot U0010-50 exp. 4/2003.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoffmann La Roche Inc., Nutley, NJ, by telephone and letters on March 1, 2002.

Manufacturer: Hoffmann-LaRoche, Nutley, NJ. Firm initiated recall is ongoing.

REASON
Potency, product crystallization causing a lack of uniformity in potency.

VOLUME OF PRODUCT IN COMMERCE
13,122 bottles.

DISTRIBUTION
Norway
.

 
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.