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SafetyAlerts
December 27, 2002

McNeil Consumer & Specialty Pharmaceuticals Has Recalled Children's Tylenol

SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
a) Children's Tylenol (Acetaminophen) Oral Suspension,
160 mg, 4 Fl oz (120mL) bottles, Bubblegum Flavor,
NDC #50580-407-04. Recall # D-096-3.
b) Children's Tylenol (Acetaminophen) Oral Suspension,
160mg, 4 Fl oz (120mL), Grape Flavor, NDC #50580-296-04.
Recall # Recall D-097-3.

CODE
a) Lot #EFM041 exp 7/04;
b) Lot #EFM040 exp 7/04.

RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA, by letter on November 20, 2002. Firm initiated recall is ongoing.

REASON
Defective container; product packaged with incorrect dosing cups marked with metric measurements rather than with U.S. standard measurements

VOLUME OF PRODUCT IN COMMERCE
116172 bottles.

DISTRIBUTION
Nationwide.

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