The FDA and Blacksmith Brands notified healthcare professionals and consumers of a nationwide voluntary recall of all lots of four PediaCare children’s products. Blacksmith Brands has initiated this recall as a precautionary step because the products were made at the McNeil Consumer Healthcare Fort Washington, PA plant that has been temporarily shut down. A recent FDA inspection at that facility found serious problems in meeting the FDA’s current good manufacturing practice requirements.
The four PediaCare products involved in the recall are:
- PediaCare Multi-Symptom Cold (dextromethorphan HBr, phenylephrine HCl) 4oz. UPC # 3 0045-0556-05 9
- PediaCare Long Acting Cough (dextromethorphan HBr) 4oz. UPC# 3 0045-0465-04 7
- PediaCare Decongestant (phenylephrine HCl) 4oz. UPC# 3 0045-0554-04 8
- PediaCare Allergy and Cold (diphenhydramine HCl, phenylephrine HCl) 4oz. UPC# 3 0045-0552-04 4
Blacksmith is advising consumers who have these products in their possession to discontinue their use.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214036.htm.