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SafetyAlerts
May 29, 2002

Ortho-Mcneil Pharmaceutical Has Recalled Ortho Micronor Oral Contraceptive

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
Ortho Micronor Oral Contraceptive Tablets (norethindrone) 0.35 mg, 28 tablets in a ring-shaped blister pack, Rx only.
Recall # D-280-2.

CODE
Trade: NDC 0062-1411-16
Lot 11M001 Exp. 11/04
Lot 11M002 Exp. 11/04
Lot 12C003 Exp. 01/05
Lot 12C004 Exp. 02/05
Physician Samples: NDC#0062-1411-29
Lot 11M019 Exp. 11/04
Refills: NDC# 0062-1411-23
Veridate 12A029 Exp. 01/05
12C030 Exp. 01/05.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Mcneil Pharmaceutical, Inc., Raritan, NJ, by letters on April 3, 2002.
Manufacturer: Ortho-Mcneil Pharmaceutical Inc., Manati, Puerto Rico.
Firm initiated recall is ongoing.

REASON
Mislabeling; labeling incorrectly informs user that missing any pills 22-28 will still leave them protected.

VOLUME OF PRODUCT IN COMMERCE
Trade -- 339,336 blisters;
Veridate -- 40,320 blisters;
Samples -- 124,704.

DISTRIBUTION
Nationwide
.

 
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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.