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McNeil issues recall on Infants’ Tylenol drug due to dosage complications

Filed February 21st, 2012 Joshua Sophy

McNeil Consumer Healthcare has issued yet another recall … this on Infants’ TYLENOL Oral Suspension, 1 oz. Grape due to complaints over the dosing system included with the over-the-counter product.

According to a recall statement issued by the company, its latest recall includes 574,000 bottles sold as part of 7 Lots distributed nationwide at the wholesale and retail level. The Infants’ TYLENOL Oral Suspension, 1 oz. Grape products included in the recall are sold with the SimpleMeasure dosing system. The following Lots are included in the recall: BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00.

Confusion with the product’s non-traditional dosing system has prompted the recall and for good reason. Accidental overdoses of over-the-counter medicines among infants and young children have resulted in a growing number emergency room visits, serious injuries and even some deaths.

The company says “if the flow restrictor is pushed into the bottle,” the product included in the recall should not be used.
The release states, “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. Children’s TYLENOL products are intended for children two years of age and older and remain available.”

McNeil believes the overall risk of complications is “remote” and said it has not received any reports of adverse events resulting from confusion with the SimpleMeasure program.

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