Wyeth recalls Kids' cough syrups due to faulty dosage cups

Wyeth Consumer Healthcare, one of the largest pharmaceutical companies in the world, on Monday issued a voluntary recall of several of its Robitussin cough, cold and congestion products and its Children's Dimetapp Cold & Chest Congestion medicine because of a dosing cup problem.

The Madison, New Jersey-based pharmaceutical giant Wyeth emphasized that recall is specifically related with the plastic measurement cup that lacks a measurement mark for young children, and not linked to the safety of these medicines.

Wyeth said the dosage cups for the affected products do not show a half-teaspoon mark to help measure a dose recommended for children ages two to six.

While announcing the voluntary recall and replacement program for all U.S. retail outlets that sell a range of children's cough and cold medicines, the drug-maker said, "This action is specific to the dosage cup and not related to the medication itself."

The products being recalled and replaced include Robitussin Cough DM, Robitussin Cough & Cold CF, Robitussin Cough & Congestion, Robitussin Chest Congestion, Robitussin Head & Chest Congestion PE, Robitussin Cough Sugar Free DM and Children's Dimetapp Cold & Chest Congestion.

Wyeth, the largest maker of hormone- replacement medicines, said consumers can continue to use Robitussin or Dimetapp products in accordance to label directions, however, it urged parents not to use these products for children aged two to six until the replacement products with the new cup are available.

The version with the correct cup, showing a clear mark on the packaging to show it contains the correct cup, is expected to be in the retail stores early next month.

Wyeth’s Monday's recall comes on the heels of advice by the advisory panel at the U.S. Food and Drug Administration, suggesting some of the cough and cold medicines that have been sold over the counter for years are associated with serious side effects and some deaths in patients younger than 6.

Earlier this week, the panel negated the safety and efficacy of the over-the-counter cough and cold remedies. The health officials conceded that the cough and cold medicines do no good and may be risky for children if not properly used. They also said the drug companies should conduct trials to prove the safety of these drugs for children.

The week before the FDA panel issued its report, the makers of more than one dozen over-the-counter infant cough and cold medicines voluntarily pulled 14 products for children under 2 from the market. The brands withdrew by the companies include Dimetapp Decongestant Plus Cough Infant Drops, Little Colds, Pediacare, Triaminic, Tylenol and Robitussin Infant Cough DM Drops.

Wyeth has issued a helpline number, 1-800-762-4675, for the concerned parents. They can either call on this number or visit the Dimetapp.com and Robitussin.com websites for more information on the issue.

The pharmaceutical company has also advised parents to better contact their doctors about the best way to treat coughs and colds in children under six.

Wyeth has described itself on its Website as one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life of people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.