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Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints‏

AUDIENCE: Consumer, Pharmacy
ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.
BACKGROUND: Infants’ TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States.
RECOMMENDATION: If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes of affected product. Consumers can visit www.tylenol.com for additional information.

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