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news.Blacksmith Brands, in consultation with the US FDA, has been voluntarily recalling all lots of four children's products in the PediaCare line, as a precautionary step as the recalled products were made at the facility that has been temporarily shut down.
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The recalled products were manufactured for Blacksmith Brands by McNeil Consumer Healthcare, a Division of McNeil-PPC, (a Johnson & Johnson company) at McNeil’s Fort Washington, Pennsylvania plant.
FDA has found that the manufacturing facility failed to meet its current manufacturing practice requirements during its recent inspection.
The recalled products are PediaCare Multi-Symptom Cold 4oz, PediaCare Long Acting Cough 4oz, PediaCare Decongestant 4oz, and PediaCare Allergy and Cold 4oz. The products are sold exclusively in the US.
Blacksmith Brands said that the recall was not initiated 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.
Blacksmith Brands is asking retail and wholesale customers to withdraw and return the products. To provide the recalled products to consumers again, it has arranged to make them at new manufacturing plants and expects to resume shipments of the recalled items in July from new facilities.
The 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.
Peter Mann, chairman and CEO of Blacksmith Brands, said: “We’re taking this voluntary step because protecting consumers and maintaining their trust are essential to our company’s core values.”
Blacksmith Brands markets, sells and distributes over-the-counter drug and personal care products.