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June 13, 2000

Danbury Pharmacal Recalls Doxycycline Hyclate Capsules

Humacao, Puerto Rico (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Danbury Pharmacal Puerto Rico, Inc., a subsidiary of Schein Pharmaceutical, Inc., is conducting a recall of Doxycycline Hyclate Capsules because the product fails (exceeds) USP water content at 9 month test point.

The products affected by this recall are:

Doxycycline Hyclate Capsules, USP, 50 MG in bottles of 50, NDC 0364-2032-50, and bottles of 100 (10 X 10), NDC 0364-2033-90

Doxycycline Hyclate Capsules, USP 100 MG in bottles of 50, NDC 0364-2033-50, and bottles of 500, NDC 0364-2033-05.

According to FDA this recall affects the lot numbers: P9A0015, expiration date JAN 01, in bottles of 50
P9A0015, expiration date OCT 00, in unit dose
P9A0018, JAN 01, in bottles of 50 and 500.

About 27,000 bottles were distributed nationwide.  The firm estimated fewer than 0.1% of the product remained on market at time of recall initiation.

This ongoing Class III recall was initiated by the company, by letter on May 3, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-394395-0

Notice of this product warning was sent via email to SafeMail subscribers June 13, 2000.

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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