June 13, 2000Danbury Pharmacal Recalls
Doxycycline Hyclate Capsules
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
The products affected by this recall
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.
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