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SafetyAlerts
November 7, 2000

Danbury Pharmacal of Puerto Rico Recalls Doxycycline Hyclate Capsules

Humacao, 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.

PRODUCT
a) Doxycycline Hyclate Capsules, USP, 50 mg, in bottles of 50, NDC #0364-2023-50;
b) Doxycycline Hyclate Capsules, 100 mg, in bottles of 50 and 500, NDC #0364-2033-05, Schein Pharmaceutical label.

Recall #D-008/009-1.

CODE
Lot Numbers: P9H0299 EXP AUG 01 and P9E0179 EXP MAY 01.

MANUFACTURER
Danbury Pharmacal of Puerto Rico, Inc., Subsidiary of Schein Pharmaeutical, Inc., Humacao, Puerto Rico.

RECALLED BY
Manufacturer, by mail on August 16, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
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.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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