Safety Alerts & Recalls
What does this mean?
No adverse events linked to the TYLENOL SimpleMeasure dosing syringe or the recalled Infants’ TYLENOL Oral Suspension, 1 oz. Grape have been reported to date and the risk of a serious adverse medical event from the recalled product is rare. Please check your medicine cabinet to see if you have any Infants' Tylenol in your home. You can continue to use these products as long as the flow restrictor at the top of the bottle remains in place. If the flow restrictor is pushed into the bottle, you should not use the product. You can request a refund by visiting www.tylenol.com or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).
For more information on how to use the SimpleMeasure System, please watch this video demonstrating how to use the TYLENOL SimpleMeasure system: http://www.youtube.com/tylenol
If you have any health questions or concerns about the use of the TYLENOL SimpleMeasure dosing syringe, you should contact your pharmacist or other healthcare provider.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints
McNeil Consumer Healthcare (“McNeil”), is voluntarily recalling some bottles of Infants’ TYLENOL Oral Suspension, 1 oz. Grape distributed in the United States. Infants’ TYLENOL is an over-the-counter (OTC) pain reliever/fever reducer. McNeil is initiating this recall as a precaution after receiving a small number of 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.
The following product lots are included in this recall: Infants' TYLENOL Oral Suspension 1oz. Grape, UPC 300450122308
Lot numbers: BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00
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