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SafetyAlerts
November 8, 2001

Paddock Laboratories Recalls Colocort, Hydrocortisone Enema

Minneapolis, MN  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Paddock Laboratories, Inc. is recalling  Colocort, Hydrocortisone Enema, USP,(Retention)100 mg/60 ml, For Rectal Use Only, Rx only, disposable, single-dose bottle.

This is the first public notice of this Class llI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
D-020-2, Colocort, Hydrocortisone Enema,USP,(Retention)100 mg/60 ml, For Rectal Use Only, Rx only, disposable, single-dose bottle, NDC Numbers 0574-2020-01 (one single 60 ml bottle in a box) and 0574-2020-07 (box of seven 60 ml bottles of the product)

Codes:
Lot numbers 9M6024, 9M6049, 9M6051, 0C6226, 0C6230, 0E6338, OE6345, 0E6360, 0E6366, 0E6372, 0H6558, 421557, 431587, 441605, 441625, 481764, and 481782

REASON:
Impurity specification failure at stability testing (18 months)

MANUFACTURER/RECALLING FIRM:
Paddock Laboratories, Inc. Minneapolis, MN

RECALLED BY:
Recalling firm, by letter, dated 10/04/2001.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
230,000 bottles.

 
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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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.