McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. is voluntarily recalling seven lots, or about 574,000 bottles, of infants’ TYLENOL® Oral Suspension, 1 ounce grape. The product has been distributed nationwide in the United States. The product is an over-the-counter pain reliever/fever reducer.
A few consumers have complained about difficulty using the Infants’ TYLENOL® SimpleMeasure® dosing system, which uses a syringe inserted into a “flow restrictor” on the top of the bottle to measure dosage. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe. This recall only affects the infants’ product. The products made for children two years and older are available.
Product details:
- Infants TYLENOL® Oral Suspension
- 1 ounce Grape
- UPC number 300450122308
- Lot Numbers
- BIL0U00
- BIL0V00
- BIL3500
- BJL2D00
- BJL2E00
- BJL2T00
- BJL2U00
No adverse reactions have been reported in association with this product to date. If the flow restrictor is pushed into the bottle, don’t use the product; request a refund by contacting the company at 1-888-222-6036 from 8:00 am to 8:00 pm EST Monday through Friday, and 9:00 am to 5:00 pm EST Saturday and Sunday.
If you don’t have problems with the flow restrictor, you can continue to use the product as long as it remains in place.
If your child does experience an adverse event related to this product, contact the FDA MedWatch Adverse Reporting Program online, through regular mail, or Fax at 1-800-FDA-01078.
