FDA Recall of Some PediCare products

Here is a recall notice from the FDA -no reports of harm, just being proactive due to manufacturing concerns.

May all babies be born into loving hands...

K. Michelle Doyle, CNM, NYS LM
www.localcaremidwifery.com
www.localcaremidwifery.blogspot.com

http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm052224.gif

PediaCare Children's Products [Blacksmith Brand]: Recall of four products

PediaCare Multi-Symptom Cold

PediaCare Long Acting Cough

PediaCare Decongestant

PediaCare Allergy and Cold

Audience: Consumers,, Pediatrics healthcare professionals

Blacksmith Brands and FDA notified healthcare professionals and patients about a nationwide recall of all lots of four PediaCare children's products. These products are sold exclusively in the United States and were manufactured by McNeil Consumer Healthcare at McNeil's Fort Washington, PA plant.

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

Blacksmith Brands initiated the recall as a precautionary step because the products were manufactued at a McNeil plant in which a recent FDA 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.

Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214036.htm