What Happened

All unexpired lots of certain over-the-counter (OTC) liquid medicines for infants and children have been voluntarily recalled because some might not meet required quality standards.

The recall has been issued in the Unites States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Kuwait, Panama, Puerto Rico, and Trinidad & Tobago by Johnson & Johnson’s McNeil Consumer Healthcare in consultation with the U.S. Food and Drug Administration (FDA).

What This Means

This latest recall includes eight OTC medicines in 43 different flavors and sizes, including:

1. Tylenol Infants’ Drops
2. Children’s Tylenol Suspensions
3. Children’s Tylenol Plus Suspensions
4. Motrin Infants’ Drops
5. Children’s Motrin Suspensions
6. Children’s Motrin Cold Suspensions
7. Children’s Zyrtec Liquids in Bottles
8. Children’s Benadryl Allergy Liquids in Bottles

McNeil is recalling the products because some might contain more of the active drug ingredient than specified, while others might have inactive ingredients that might not meet internal testing requirements, or may contain tiny particles. Information about the specific lots recalled is on McNeil’s recall website; affected product NDC numbers are on the label of the bottle above the brand name.

The company advises consumers to stop using these products immediately, although it believes that the potential for serious medical problems is remote. No adverse medical reactions have been reported.

The company is investigating the Fort Washington, PA, plant where the recalled products were made to ensure there are no other problems, and plans to take corrective actions before restarting production.

Where These Products Were Sold

Drugstores, grocery stores, and other retailers in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Kuwait, Panama, Puerto Rico, and Trinidad & Tobago.

What to Do Next

Check the firm’s recall website to see if you have any packages included in the recall. If so, stop using them immediately and contact McNeil for a refund (either for the average product retail price or a coupon for a free replacement when the product is available again).

Should your child need medicine included in the recall, the FDA advises that generic versions of these products are widely available and not affected by the recall. Check the product labeling for use in children, and if you have questions, talk to your doctor or pharmacist. Do not give kids adult-strength medicine, as it may result in serious harm.

For More Information

• McNeil Consumer Healthcare:
  • call (888) 222-6036 Monday through Friday, 8 A.M.-10 P.M. ET; weekends, 9 A.M.-5 P.M. ET
  • visit the firm’s website
• To report an adverse reaction to the FDA’s MedWatch Program
• Information on safe disposal of OTC medications
• FDA news release

Recall date: April 30, 2010

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