The U.S. Food and Drug Administration has announced a voluntary recall by Blacksmith Brands for four kinds of PediaCare children's products. The agency notified health-care professionals and patients about a nationwide recall of all lots of four PediaCare medicines, sold exclusively in the United States and manufactured by McNeil Consumer Healthcare in Pennsylvania.
The four PediaCare items involved in the recall are:
- PediaCare Multi-Symptom Cold, four ounce, UPC No. 3 0045-0556-05 9
- PediaCare Long Acting Cough, four ounce, UPC No. 3 0045-0465-04 7
- PediaCare Decongestant, four ounce, UPC No. 3 0045-0554-04 8
- PediaCare Allergy and Cold, four ounce, UPC No. 3 0045-0552-04 4
Blacksmith Brands initiated the recall as a precautionary step because the products were manufactured at a McNeil plant in which a recent inspection found serious problems in meeting FDA's current good manufacturing practice requirements. The company advises consumers who have purchased these recalled products to discontinue use.
For more information, go to http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214036.htm.