The U.S. Food and Drug Administration (FDA) has announced that Blacksmith Brands Inc. is recalling all lots of four children's products in the PediaCare line because they were made at a McNeil Consumer Healthcare plant shut down for violating FDA's manufacturing standards.
The four PediaCare items involved in the recall are:
• PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
• PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
• PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
• PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4
Items not involved in this recall are PediaCare Allergy 4oz., PediaCare Gentle Vapors Plug in Units, and PediaCare Gentle Vapors refills, all of which are produced in other facilities.
Blacksmith Brands said it had not received any reports of problems with the products, although tiny particles have been found in non_pediaCare products manufactured at the McNeil facility. The McNeil plant in Fort Washington, PA, was temporarily shut down after an FDA inspection found "serious problems in meeting the FDA's current good manufacturing practice requirements."
The company advises consumers who have purchased these recalled products to stop using them. Blacksmith Brands is asking retail and wholesale customers to withdraw the four products from their shelves and warehouses and return the product to Blacksmith Brands.
Blacksmith said it has arranged to make the PediaCare products at new manufacturing plants and expects to resume shipments of the recalled items in July from those new facilities.
Consumers with questions may contact Blacksmith Brands on Friday, May 28th 5pm 9pm EST; Saturday-Monday 9am-5pm EST; and normal business hours thereafter at (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 fda.gov/safety/medwatch/default.htm.
"We're taking this voluntary step because protecting consumers and maintaining their trust are essential to our company's core values," said Blacksmith Brands Chairman and CEO Peter Mann. "Our brands have a heritage that has made them the favorites of millions of families and we are the guardians of that heritage."