Recalls

McNeil recalls half-million bottles of infants Tylenol Oral Suspension

Approximately 574,000 bottles of infants Tylenol Oral Suspension, 1 Oz. Grape have been recalled due to complaints from consumers who reported difficulty using the Infants’ Tylenol SimpleMeasure dosing system. The system includes a dosing syringe, which the 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.

Infants’ Tylenol is sold over-the-counter, without a prescription, to treat pain or reduce fever in infants. It was distributed nationwide at drug stores and grocery stores and other retail outlets. The medicine was made at McNeil Consumer Healthcare, the same plant that manufactured the millions of over-the-counter medicines, including Tylenol, that were recalled due to poor quality measures, possible contaminations, and foul smelling bottles.

The latest recall due to dosing issues involves Infants’ Tylenol Oral Suspension 1 oz. Grape with the UPC code of 300450122308 and one of the following lot numbers: BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00.

No adverse events were associated with the dosing problem, and McNeil says the risk of problems is remote. Consumers can continue to use Infants’ Tylenol if the flow restrictor at the top of the bottle remains in place. If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. Refunds can be requested at www.tylenol.com or by contacting McNeil at 1-888-222-6036. Parents and caregivers with questions should contact their doctors or visit www.tylenol.com for more information.

Source: FDA