Questions and Answers
Which products contain a higher concentration of active ingredient?
Only one product, concentrated TYLENOL® Infants’ Drops 1 oz Cherry Dye Free (NDC: 50580-167-01), was identified as potentially containing a higher concentration of active ingredient than specified on the label.
Are any recalled products contaminated with bacteria?
To our knowledge, no bacterially contaminated components were used in the final manufacture of any of our recently recalled products. Also, testing done to date has not found bacteria in any components used to make finished products or in the finished products themselves.
What kind of particles are in the recalled products?
Some of the recalled products may contain solidified product ingredients or manufacturing residue, such as tiny metal specks. The number, shape, composition and size of the particles makes the potential risk of serious medical events remote. Patients should discontinue use of all recalled products.
Was this recall conducted due to reports of adverse events?
This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, patients should discontinue use of these products. Any adverse reactions may be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
When will these products be available again?
The company is continuing to conduct a comprehensive quality assessment across its manufacturing operations. Only after this assessment is complete and corrective actions are identified and implemented will new manufacturing be initiated and products be available from the plant where the recalled products were made.
Can patients get a refund or coupon?
McNeil is offering two options for patients who have purchased products affected by this recall. Patients can receive either a refund for the average retail price of the product or a coupon for a free replacement(s) when the product becomes available again. Patients looking for information about a refund or coupon for recalled product can either visit www.mcneilproductrecall.com or call the company at 1-888-222-6036.
What single-ingredient acetaminophen-containing medicines are available for pediatric patients?
Pediatric acetaminophen liquid products are available from other manufacturers for use in infants and children. In addition, children between the ages of 2 and 5 years old can use Children’s TYLENOL® (acetaminophen) Meltaways. Children between the ages of 6 and 11 years old can use Junior Strength TYLENOL® (acetaminophen) Meltaways. Remember to counsel parents and caregivers to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
What single-ingredient ibuprofen-containing medicines are available for pediatric patients?
Pediatric ibuprofen liquid products are available from other manufacturers for use in infants and children. In addition, children between the ages of 2 and 11 years old can use Junior Strength MOTRIN® (ibuprofen) Chewables. Children between the ages of 6 and 11 years old can use Junior Strength MOTRIN® (ibuprofen) swallowable Caplets. Remember to counsel parents and caregivers to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
What single-ingredient cetirizine-containing medicines are available for pediatric patients?
Pediatric cetirizine liquid products are available from other manufacturers for use in children. Children 6 years old and older, who can swallow pills, can use regular ZYRTEC®. Remember to counsel parents and caregivers never to give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
Are any single-ingredient BENADRYL® (diphenhydramine) products available for pediatric patients?
Some single-ingredient pediatric liquid BENADRYL® (diphenhydramine) medicines remain on the market. In addition, for children ages 6 years old and over, you can use Children’s BENADRYL® Perfect Measure which is a unit-dose liquid product. For children 6 years old and over Children’s BENADRYL® FastMelts are also available. Remember to counsel parents and caregivers to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
