In coordination with the FDA, McNeil Consumer Healthcare, a division of Johnson & Johnson, has initiated a voluntary recall of common OTC children’s cold, allergy, and pain medications, the agency announced Saturday.
Products included in the recall are oral suspensions of infant’s and children’s Tylenol, Motrin, Zyrtec, and Benadryl, which have “manufacturing deficiencies that may affect their quality, purity, or potency,” the FDA said in a statement. Although no adverse effects have been reported, McNeil advised parents and caregivers not to administer any of the recalled products to children.
Some of the affected medications may contain higher concentrations of active ingredients or sub-standard inactive ingredients. Still others might be contaminated with “tiny particles,” which a McNeil company spokesman told the New York Times could be either “solidified product ingredients or manufacturing residue, such as tiny metal specks.”
The FDA is currently conducting an investigation to determine the cause behind the flaws. In the meantime, the agency said parents should:
• discuss with a pharmacist or other health care professional whether an appropriate generic alternative is available;
• monitor children who have already received a dose of the affected medication for adverse effects or quality issues;
• report any adverse reactions or unexpected symptoms to a health care professional, as well as the FDA’s MedWatch Adverse Event Reporting program.
The announcement by McNeil Consumer Healthcare echoed these points and reminded parents never to give adult-strength drug products to infants and children, a practice which “could result in serious harm,” the company warned.
McNeil said it also initiated an internal review of its facilities and operations and has identified “corrective actions” that must be implemented before production resumes at the affected manufacturing plants.
To view a complete list of recalled products, including NDC numbers, read the original release from McNeil Consumer Healthcare.
To report an adverse reaction to children’s Tylenol, Motrin, Zyrtec, or Benadryl, visit the FDA’s MedWatch Web site. Adverse reactions can also be reported by fax at 1-800-FDA-0178, or by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
To contact McNeil Consumer Healthcare directly, visit the company’s product recall Web site or call 1-888-222-6036. Representatives will be available Monday through Friday from 8:00 AM to 10:00 PM and on weekends from 9:00 AM to 5:00 PM, Eastern time.