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December 6, 2000

Wyeth-Ayerst Laboratories Recalls Prescription Conjugated Estrogen Tablets

Please see Company Addendum

Richmond, VA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Wyeth-Ayerst Laboratories is recalling certain prescription conjugated estrogen tablets because of dissolution failure.

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

Prescription Conjugated Estrogen Tablets:
a) Premarin (conjugated estrogens tablets), 0.625 mg, in:
100-tablet bottles (NDC #0046-0867-81);
1000-tablet bottles (NDC #0046-0867-91);
5000-tablet bottles (NDC #0046-0867-95)

b) Premarin (conjugated estrogens tablets), 0.9 mg, in 100-tablet bottles (NDC #0046-0864-81)

c) Premarin (conjugated estrogens tablets), 1.25 mg, in 5000-tablet bottles (NDC #0046-0866-95)

d) Premarin (conjugated estrogens tablets), 2.5 mg, in:
100-tablet bottles (NDC 0046-0865-81);
1000-tablet bottles (NDC 0046-0865-91)

e) Premphase 0.625 mg/5 mg tablets (conjugated estrogens/ Medroxyprogesterone acetate), in EZ-dial dispensers (NDC #0046-2573-06).

Recall #D-039/043-1.

a) 100-tablet bottle Lot #s: 9990085, 9990358, 9990583, and 9990584, EXP dates: September 2002 through December 2003; 1000-tablet bottle Lot #s: 9980880, 9990086 EXP Dates: September 2002 and January 2003;
5000-tablet bottle Lot #s: 9980299, 9981799, 9990290, 9990297, 9990298, and 9990585 EXP Dates: September 2002 through December 2003;

b) 100-tablet bottle Lot #s: 9980266, 9980282, 9980649, 9980869, 9981043, 9981044, 9981200, 9981201, 9981497, 9981585, 9981730, 9990074, 9990075, 9990173, 9990174, 9990279, 9990280, 9990281, 9990403, 9990404, 9990405, 9990569, 9990570, 9990571, 9990572, 9990705, 9990958, 9990959, 9990960, 9991012, 9991017, 9991165, 9991283, 9991377 EXP Dates: September 2002 through April 2004;

c) 5000-tablet bottle Lot #9980874, EXP February 2003.

d) 100-tablet bottle Lot #9990282 EXP October 2003;
1000-tablet bottle Lot #s: 9990175 and 9990283 EXP Dates: October 2003

e) EZ Dial Dispenser: Lot #9990235, EXP June 2001.

MANUFACTURER (Responsible Firm) Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, New York, and Wyeth Pharmaceuticals Company, Guayma, Puerto Rico.

Wyeth-Ayerst Laboratories, Richmond, Virginia by letter dated October 16, 2000. Firm-initiated recall ongoing.

Nationwide and Malta.

a) 154,977 100-tablet bottles, 27,351 1000-tablet bottles, and 16,348 5000-tablet bottles;
b) 2,393,436 100-tablet bottles;
c) 2,378 5000-tablet bottles;
d) 8,304 100-tablet bottles and 6,256 1000-tablet bottles;
e) 41,220 units were distributed.

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

Please see Company Addendum

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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