Alertas de Segurança e Recolhimento de medicamento

O que significa isto?

The recall was not issued as a result of any consumer reports of adverse events and no consumer complaints have been received about the safety or purity of the products has been received to date. While the recall was not issued as a result of any complaints with respect to the PediaCare products, tiny particles have been found in other non-PediaCare products which were manufactured at the McNeil plant.

Although the risk of illness or health problems in a child or infant following the use of these recalled Pediacare products is remote, Blacksmith Brands advises consumers who have purchased these recalled products to stop using them. If your child is experiencing any unexpected symptoms after using of any of the recalled products, contact your healthcare professional. Any adverse reactions may also be reported to the FDA's MedWatch Program by telephone at 1-800-332-1088 by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Please contact Blacksmith Brands consumer hotline at (888) 474-3099 or view their website if you have any further questions or would like to receive a coupon for a free product replacement. To process your free product coupon you will need the NDC number and Lot number from the product. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label.

All Lots of Four Select PediaCare Products Recalled

Blacksmith Brands, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots of four children's products in the PediaCare line.

The four PediaCare items involved in the recall are: 1. PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9 (contains dextromethorphan and phenylephrine)

2. PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7 (contains dextromethorphan)

3. PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8 (contains phenylephrine)

4. PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4 (contains diphenhydramine and phenylephrine)

Blacksmith Brands has issued this recall as a precautionary step because the products were made at the McNeil Consumer Healthcare Fort Washington, Pennsylvania 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 and led to a recall of several McNeil Consumer Healthcare products.

Items NOT involved in this recall are PediaCare Allergy 4oz., PediaCare Gentle Vapors Plug in Units, and PediaCare Gentle Vapors refills, all of which are produced in other facilities.

For more information, please visit: mais informações aqui

To view Pediacare Recall Frequently Asked Questions webpage, please visit: mais informações aqui

Fonte: Manufacturer
Data de publicação: 2010-06-01
Última atualização: 2010-06-01
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