April 12, 2001Aptoex Corp. Recalls Midazolam
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.
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
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
Novex Pharma, Ontario, Canada.
Aptoex Corp., Vernon Hills, IL, by letters dated 3/6/01. Firm-initiated recall ongoing.
California, Michigan, Washington, Hawaii and Oregon.
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.