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SafetyAlerts
April 2, 2003

Warner Chilcott Labs Has Recalled Doryx Capsules

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

PRODUCT
Doryx Capsules (coated doxycycline hyclate pellets) 75mg, 6 blisterpack physician samples (2 tablets each) and 60 count bottles, Rx only. Recall # D-189-3.

CODE
Lot numbers: 60 tablet bottles 60722662 Exp. 10/03;
60722690 Exp. 10/03; 60722663 Exp. 10/03.
Lot numbers: Physician Samples unit dose (Blisters)
60725446 Exp. 10/03; 60725446A Exp. 10/03;
60735786 Exp. 12/03; 60735786A Exp. 12/03;
1896 Exp. 3/03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Warner Chilcott Labs, Rockaway, NJ, by letter on November 21, 2002.
Manufacturer: Faulding Pharmaceutical/DBL, a division of F. H. Faulding & Co., Limited, Salisbury, South Australia. Firm initiated recall is ongoing.

REASON
Lack of assurance of stability throughout labeled expiration.

VOLUME OF PRODUCT IN COMMERCE
51,858 bottles; 174,541 bliste
rs.
 

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