April 4, 2001FDA First Notice: THE
International Medication Systems LTD. Recalls Hydromorphone HCL Injection
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.
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
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.