FDA Recall Roundup and issues with CDC website (2/15/2025)

What has been recalled? Missing data from the CDC's website

It appears that the communications pause is mostly lifted, but by request I will continue these updates for now. Current as of 11:00AM EST (2/15/2025).

Food and Drug Recall summary

ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.

ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of POTASSIUM CHLORIDE due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place

Risk Statement: If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes. ICU Medical has not received reports of adverse events associated with this issue to date.

Potassium Chloride Injection 20 mEq and 10 mEq, is indicated in the treatment of potassium deficiency states, when oral replacement is not feasible and is packaged in 100 mL bags. The mislabeled POTASSIUM CHLORIDE Inj. 20 mEq, 100 mL bags contain incorrect overwrap labels with the following information: NDC 0990-7074-26, 200 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq. The lot 1023172 and Exp. Date 31 January 2026 is found on the primary container (see picture below). These mislabeled bags are packaged in cases labeled: NDC 0990-7075-26, CASE PACK 1x24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO. 1023172, EXP DATE 2026-01.

ICU Medical is notifying its customers, including distributors, of this recall by letter, and is arranging for the return of all recalled product. All Health Care professionals that have product that is being recalled should stop use/further distribution, as applicable, and return to place of purchase.

Consumers with questions regarding this recall can contact ICU Medical by phone number or e-mail address as indicated in the table below. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For further inquiries, please contact ICU Medical using the information provided below

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: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

There is some data and webpages still missing on the CDC’s website

A recent executive order caused the CDC to take down several datasets and webpages to be in compliance. However, last Tuesday, a federal judge ordered for the data to be restored and that it should go back online by Friday. Today is Saturday, February 15, and there is still some data that is not available.

An online tool to navigate results from about adults called the Behavioral Risk Factor Surveillance System is still down.

The Behavioral Risk Factor Surveillance System (BRFSS) is the nation’s premier system of health-related telephone surveys that collect state data about U.S. residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services. Established in 1984 with 15 states, BRFSS now collects data in all 50 states as well as the District of Columbia and three U.S. territories. BRFSS completes more than 400,000 adult interviews each year, making it the largest continuously conducted health survey system in the world.

The FDA's posts on how it was easing restrictions for gay men to donate blood also remain offline. The agency's final guidance to blood banks can still be found by searching the FDA website, but it has been quietly scrubbed of all mentions of gender.

"Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so," FDA Commissioner Robert Califf had said in a now-deleted announcement from 2023 about the change. (SOURCE CBS News)

I will keep an eye out to see if any changes are made and keep you informed as best as I can.

---

Please subscribe to continue receiving regular updates that may involve your health. While not required, any support is greatly appreciated.