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Tags Posts tagged with "FDA"

FDA

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The Office of Developmental Programs (ODP) wishes to create awareness of a recent announcement from the U.S. Food and Drug Administration (FDA) recommending consumers, health care providers, and facilities not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard. For access to additional details, please visit “FDA Safety Communication: O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks.”

If this creates a hardship to a provider, please reach out to Douglas Trahey electronically.

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The Office of Developmental Programs is issuing this Health Alert to bring awareness that GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care First Aid® AfterBurn® Cream, 0.9 g single-use packets. FDA analysis found the product to be contaminated with Bacillus licheniformis and Bacillus sonorensis.

This recall is to the consumer level. The single use packets are sold in:

  • boxes of 10; or
  • packaged in certain First Aid kits.

The Food and Drug Administration (FDA) recently issued a Safety Communication that provides additional details and information, including guidance for people who have used or have purchased the affected product and their caregivers.

If you have used or have purchased one of these affected products, talk to your health care provider to decide on a suitable alternative and discuss if additional treatment is necessary because of using the recalled products. Additionally, please follow the recommendations provided by the FDA.

Where to Learn More:

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FDA Safety Advisory (Issued June 28, 2022): Do not use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special health care needs.

See the full FDA Communication here.

If you have any questions, please contact RCPA Children’s Policy Director Jim Sharp. Please share with those in your networks. Thank you.

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