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FDA

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The Office of Developmental Programs (ODP) is sharing an important announcement from the U.S. Food and Drug Administration (FDA) warning individuals of the risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGM). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own. If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.

View the FDA alert here.

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The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about a recall of two cough medicine products by Robitussin. The products are Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult. Please see the specific Lot Numbers below that are involved in the recall.  If you have one of these products with the matching Lot Number, stop use immediately and contact your health care provider.

Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination

Summary
Company Announcement Date: January 24, 2024
FDA Publish Date: January 24, 2024
Product Type: Drugs
Reason for Announcement: Microbial Contamination
Company Name: Haleon
Brand Name: Robitussin
Product Description: Cough syrups

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination.

In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events, such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out. To date, Haleon has not received any reports of adverse events related to this recall.

Robitussin Honey CF Max Day and Nighttime are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies. This recall covers only the following lots:

Product Lot Number Expiry Date
ROBITUSSIN HONEY CF MAX
DAY ADULT 4OZ		 T10810 31OCT2025
ROBITUSSIN HONEY CF MAX
DAY ADULT 8OZ		 T08730
T08731
T08732
T08733
T10808		 31MAY2025
31MAY2025
31MAY2025
31MAY2025
30SEP2025
ROBITUSSIN HONEY CF MAX
NT ADULT 8OZ		 T08740 T08742 30JUN2026
30JUN2026

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers that have purchased the product listed should stop consumption immediately. Please call our Consumer Relations team at +1-800-245-1040 (Monday through Friday 8:00 am – 6:00 pm Eastern Time) or reach out via email.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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The Office of Developmental Programs (ODP) has shared important information about eye drops from the U.S. Food and Drug Administration. Eye drops from the 26 products listed here in the FDA MedWatch warning should not be used. CVS, Rite Aid, and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby, and Velocity may still be available to purchase in stores and online and should not be purchased.

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The Office of Developmental Programs (ODP) has shared the following recall information announced by the U.S. Food and Drug Administration (FDA):

Dr. Berne’s Whole Health Products is recalling all lots of MSM DROPS 5% 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution because FDA analysis has found one lot (lot 6786) of Dr. Berne’s MSM DROPS 5% Solution to fail sterility, with both bacterial and fungal contamination found in the product. Out of an abundance of caution, Dr. Berne’s is recalling all other lots of the 5% and 15% strengths of MSM Solution and all lots of Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution. These products are used as lubricating eye drops.

RISK STATEMENT: Using contaminated eye drops could result in minor to serious vision-threatening infection, which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall.

RECOMMENDATIONS:

  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
  • Consumers/distributors/retailers that have product which is being recalled should stop using and return to the company Sun Star Organics.
  • Consumers with questions regarding this recall can contact Dr. Berne’s Whole Health Products.

Further information is available here.

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Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. During testing, the firm found polyether polyurethane (PE-PUR) in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.

Please be aware, this recall is a voluntary correction, not a product removal.

Clinicians may continue to use the devices with adult patients and are instructed to not use the devices with pediatric patients.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Read more here.

If you have questions about this recall, contact Draeger Service Technical Support between the hours of 8:00 am – 8:00 pm EST at 800-437-2437 (press 2 at the prompt, then 2 again).

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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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