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SafetyAlerts
May 21, 2003

Abbott Laboratories Has Recalled Various Drugs

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Liposyn II 10%, Intravenous Fat Emulsion, 500 mL single
dose containers, Rx only. Recall # D-241-3;
b) Liposyn II 20%, Intravenous Fat Emulsion, 200 mL and 500
mL single dose containers, Rx only, Recall # D-242-3;
c) Liposyn III 10%, Intravenous Fat Emulsion, 500 mL single
dose containers, Rx only. Recall # D-243-3;
d) Liposyn III 20% Intravenous Fat Emulsion, 500 mL single
dose containers, Rx only. Recall # D-244-3;
e) Liposyn III 30%, Intravenous Fat Emulsion, 500 mL single
dose glass bottle, Rx only, Pharmacy Bulk Package, Not
for Direct Infusion Recall # D-245-3;
f) Propofol Abbott Injection, 10 mg/mL, 20mL, 50mL, 100mL
vials and 20 mL Ampoules, Emulsion for IV Injection or
Infusion Sterile, Abbott Laboratories, North Chicago, IL
60064 Also sold as: Propofol Injection, 200mg/20mL,
Abbott Australasia PTY LYD, Kurnell 2231 Australia,
Abbott Laboratories (NZ) LTD, Naenae Lower Hutt New
Zealand Propofol Emulsion Inyectable I.V., 10 mg/mL,
500mg en 50 mL vial, Manufacturado por: Abbott
Laboratories, North Chicago, IL 60064, USA Propofol
Injection/Injectable, Abbott Laboratories Limited,
Laboratoires Abbott Limitee, Saint-Laurent, Qc H4S 1Z1
Propocam, Propofol.Emulsion Inyectable, 200mg, Fabricado
en Estados Unidos por: Abbott Laboratories North
Chicago, IL, Acondicionado y distribuido en Mexico por;
Abbott Laboratories de Mexico SA de CV Av Coyoacan No
1622, Col del Valle CP 03100, Mexico Propofol
Medicamento Generico Lei, 10 mg/ml, 5 frascos-ampola de
20 ml, Abbott Laboratories do Brasil Ltda PropoFlo,
propofol Ph Eur 10 mg/ml, 20 ml vials, injectable
anaesthetic for dogs and cats, Manufactured for: Abbott
Laboratories, Queenborough, Kent ME11 5EL, By Abbott
Laboratories, North Chicago, IL. Recall # D-246-3.

CODE
a) Lot 85396DE;
b) Lots 85394DE; 85393DE (200mL); Lots 84363DE, 84364DE,
85385DE, 85390DE, 85400DE, 84362DE, 85399DE (500mL).
c) Lot 85389DE;
d) Lots 84365DE, 84374DE, 84378DE, 85384DE, 85387DE,
85388DE, 85397DE, 85398DE, 85401DE;
e) Lot 84381DE;
f) Lots 84850Z7, 85718Z7, 84851Z7, 84839X7, 85712Z7,
85715Z7, 85726Z7, 84843Z7, 85711Z7, 85714Z7, 85717Z7,
84849Z7, 84842Z7, 85710Z7, 85724Z7, 85725Z7, 84841Z7,
84959Z7 (vet product).

RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated March 31, 2003. Firm initiated recall is
ongoing.

REASON
Contaminated, product contains stainless steel particles.

VOLUME OF PRODUCT IN COMMERCE
157,164 bottles; 449,520 vials.

DISTRIBUTION
Nationwide, and Canada, Singapore, Thailand, Turkey, Lithuania, Bosnia, Pakistan, Australia, Mexico,
Malaysia, Hong Kong, Malta, Croatia, Bulgaria, Brazil, England, Italy. Please Note: The Propofol products
were not distributed in the US.

 
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.