May 23, 2002
B. Braun Medical Has Recalled FreAmine III
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
VERSED Syrup (midazolam HCl) CIV, 118 ml (2mg/mL) bottles, Rx only. Recall #
Lot U0009-50 exp. 4/2003
Lot U0010-50 exp. 4/2003.
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
Potency, product crystallization causing a lack of uniformity in potency.
VOLUME OF PRODUCT IN COMMERCE