Tarrytown-Based Company Recalls Child Allergy Medication

A Tarrytown-based company has initiated a voluntary recall of four types of children's allergy and cold medicine products that were manufactured in a Pennsylvania plant that has come under FDA scrutiny.

The recall was announced on Friday and comes after the U.S. Food and Drug Administration initiated a thorough investigation into McNeil Consumer Healthcare manufacturing plants around the world. The Johnson and Johnson-owned manufacturer has been plagued with customer complaints, and an FDA inspection found numerous quality-control problems and bacterial infections at the plant and foreign materials in over-the-counter medicines. 

Blacksmith Brands is the Tarrytown-based company that markets, sells and distributes over-the-counter drugs in the United States such as Luden's throat lozenges. Four of its popular PediaCare products are being voluntarily recalled because they were produced in one of the McNeil facilities.

Although they had no hand in making the product, Blacksmith Brands said they are initiating a voluntary recall after consultation with the FDA.

"Blacksmith Brands initiated the recall as a precautionary step," a company release said. "The company advises consumers who have purchased these recalled products to discontinue use."

The four PediaCare items involved in the recall are:

1. PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
2. PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
3. PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
4. PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

"We're taking this voluntary step because protecting consumers and maintaining their trust are essential to our company's core values," the company's CEO, Peter Mann, said.

The FDA and Blacksmith Brands released a joint statement that indicated the recall was "not initiated as a result of any consumer reports of adverse events." The report went on to state that no consumer complaints have been received about the safety or purity of PediaCare products.

While PediaCare products seem to have been spared from the problems found at the Pennsylvania plant, other popular over-the-counter drugs were not so fortunate. McNeil issued a voluntary recall for over 40 medications at the end of April. The recall included popular products such as Tylenol and Motrin for children (see a full list here). The company has issued three recalls for over-the-counter children's medicines since September. Work at McNeil's manufacturing facility in Fort Washington, PA has since been suspended.

The FDA notes that the potential for serious medical events is remote, but retail and wholesale customers are being asked to withdraw the four products from their shelves and warehouses and return the product to Blacksmith Brands.  

For its part, Blacksmith Brands has arranged for their products to be made at different manufacturing plants and expects to resume shipments of the recalled items in July.

Consumers with questions may contact Blacksmith Brands at 1-888-474-3099. More information is available at blacksmithbrands.com.

Any adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. or on the Med watch website at http://www.fda.gov/safety/medwatch/default.htm