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November 21, 2000

Wyeth Ayerst Laboratories Recalls Meperidine HCL and  Heparin Sodium Injections

West 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.

PRODUCT
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.

Recall #D-018/019-1.

CODE
Lot Numbers:

a) 2990430 EXP 1/01 and 2990431 EXP 1/01;
b) 2991816 EXP 2/01.

MANUFACTURER
Wyeth Ayerst Laboratories, West Chester, Pennsylvania.

RECALLED BY
Manufacturer, by letter on September 18, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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