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PediaCare Children's Multi-Symptom Cold FDA Alerts

The FDA Alerts below may be specifically about PediaCare Children's Multi-Symptom Cold or relate to a group or class of drugs which include PediaCare Children's Multi-Symptom Cold.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for PediaCare Children's Multi-Symptom Cold

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

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 manufactured 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.

[05/28/2010 - Press Release - Blacksmith Brands]

    

Dextromethorphan

FDA issued a Talk Paper to notify the public about the abuse of dextromethorphan (DXM), an ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.

[May 20, 2005 - Talk Paper - FDA]


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