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SafetyAlerts
October 18, 2001

McNeil Consumer Healthcare Recalls Women's Tylenol Menstrual Relief Caplets

Fort Washington, PA (SafetyAlerts) - The Food and Drug Administration (FDA) said that McNeil Consumer Healthcare is recalling  Women's Tylenol Menstrual Relief Caplets. The OTC Product is 500 mg acetaminophen and 25 mg pamabron film coated caplets. The product is sold in 40 count bottles.

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

RECALL NUMBER, PRODUCT AND CODE:
D-313-1, Women's Tylenol Menstrual Relief Caplets. The OTC Product is 500 mg acetaminophen and 25 mg pamabron film coated caplets. The product is sold in 40 count bottles.

Codes:
Lot DJM099 exp. 9/02

REASON:
Dissolution Failure - Acetaminophen component (STABILITY)

MANUFACTURER:
McNeil Consumer Healthcare Guelph, Ontario, Canada

RECALLED BY:
McNeil Consumer Healthcare, Fort Washington, PA, via letter on 8/24/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
133,296 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.