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April 4, 2001

FDA First Notice: THE International Medication Systems LTD. Recalls Hydromorphone HCL Injection

South EL Monte, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that THE International Medication Systems LTD. has recalled certain Hydromorphone HCL Injection because of stability; Failure to meet potency specification prior to Labeled expiry (Subpotency).

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

(Rx) Hydromorphone HCL Injection, USP, 4 mg/20mL (0.2 mg/mL), 20 mL vial.

Recall #D-148-1.

LOT NOS. SV000E0 and SV001E0, and SV002E0.

THE International Medication Systems LTD., South EL Monte, CA.

Manufacturer, by certified letter on Dec. 7, 2000.
Firm-initiated recall ongoing.

AL    CO    GA    KY    MI     MS    NY    TN    WA
AZ    CT    IL    LA    MN     NC    OH    TX    WI
CA    FL    IN    MA    MO     NJ    PA    VA

23,990 units.

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

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.