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SafetyAlerts
April 12, 2001

Aptoex Corp. Recalls Midazolam HCl Injections

Vernon Hills, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Aptoex Corp. has recalled certain Midazolam HCl Injections because of a lack of assurance of sterility - cracks in some vials.

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

PRODUCT
Midazolam HCl Injection, 1 mg/ ml and 5 mg/ml; the product was filled in 3.5 ml vials, 10 vials per carton, in the following strengths and sizes:
a) 1 mg/ml - 2 ml fill vial, NDC 60505-0711-1. Recall #D-156-1;
b) 5 mg/ml - 1 ml fill vial, NDC 60505-0712-1. Recall #D-157-1.
2 ml fill vial, NDC 60505-0712-2

CODE:
a) 1 mg/ml: 2 ml vials, lots 0C590, 0C630, 0C640, 0C960,
0C970, 0D670, 0D750
b) 5 mg/ml: 1 ml vials, lots 0C810, 0C820, 0C910
2 ml vials, lots 0C900, 0C980

Manufacturer:
Novex Pharma, Ontario, Canada.

RECALLED BY:
Aptoex Corp., Vernon Hills, IL, by letters dated 3/6/01. Firm-initiated recall ongoing.

DISTRIBUTION:
California, Michigan, Washington, Hawaii and Oregon.

QUANTITY:
64320 2 ml vials-1 mg., 3110 1 ml vials & 3890 2 ml vials-5mg.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers April 12, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
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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.