November 21, 2000Wyeth Ayerst Laboratories
Recalls Meperidine HCL and Heparin Sodium Injections
Chester, PA (SafetyAlerts) - The
Food and Drug Administration (FDA) said today that Wyeth Ayerst Laboratories is recalling
certain Meperidine HCL and Heparin Sodium Injections because of current good
manufacturing practice deviations (lack of assurance of sterility).
This is the first public notice of
this Class II
issued by FDA.
a) Meperidine HCL Injection, USP, 75 mg per mL, 1 mL fill in 2 mL size,
used for the relief of moderate to severe pain, preoperative medication, support of
anesthesia, and obstetrical analgesia. NDC #0008-0605-2 and NDC #0008-0605-50;
b) Heparin Sodium Injection, USP, 5,000 USP units per
0.5 mL fill in 1 mL tubex(r) 10,000 USP units per mL, Rx indicated for anticoagulant
therapy. NDC #0008-0277-02.
a) 2990430 EXP 1/01 and 2990431 EXP 1/01;
b) 2991816 EXP 2/01.
Wyeth Ayerst Laboratories, West Chester, Pennsylvania.
Manufacturer, by letter on September 18, 2000. Firm-initiated recall ongoing.
a) 350,490 tubexes; b) 186,390 tubexes were distributed.
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 November
21, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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