November 7, 2000Danbury Pharmacal of Puerto Rico
Recalls Doxycycline Hyclate Capsules
Puerto Rico (SafetyAlerts) - The
Food and Drug Administration (FDA) said today that Danbury Pharmacal of Puerto Rico, Inc.
is recalling certain Doxycycline Hyclate Capsules because the product exceeds USP limit
for water content.
This is the first public notice of
this Class III
issued by FDA.
a) Doxycycline Hyclate Capsules, USP, 50 mg, in bottles of 50, NDC
b) Doxycycline Hyclate Capsules, 100 mg, in bottles of 50 and 500, NDC
#0364-2033-05, Schein Pharmaceutical label.
Lot Numbers: P9H0299 EXP AUG 01 and P9E0179 EXP MAY 01.
Danbury Pharmacal of Puerto Rico, Inc., Subsidiary of Schein Pharmaeutical, Inc., Humacao,
Manufacturer, by mail on August 16, 2000. Firm-initiated recall ongoing.
Nationwide and international.
7,590 bottles of 50 (lot P9H0299); 28,205 bottles of 50 (lot P9E0179) and 2,888 bottles of
500 (lot P9E0179) were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
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