PediaCare Children's Products [Blacksmith Brand]: Recall of four products - The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices

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Title: PediaCare Children's Products [Blacksmith Brand]: Recall of four products - The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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