Misprinted label on sodium chloride bag
An organization that purchased 0.9% sodium chloride injection USP (NDC 0264-5802-00) 1,000 mL bags (lot number 0061852531, expiration 2025-02-28) by B. Braun received a product that appeared to be labeled as 9% sodium chloride injection USP (see B. Braun infusion bag). The ISMP is uncertain if other lot numbers are impacted.
The ISMP reached out to the manufacturer to notify them of this issue. They said they are still investigating, but it appears that the ink did not properly adhere to the bag. So, for now, inspect your supply of 1,000 mL B. Braun 0.9% sodium chloride injection USP bags and notify the manufacturer if you have or receive an impacted product.
Safety issue with probiotic packaging
Healthcare practitioners have reported concerns with the packaging for EVIVO (activated Bifidobacterium infantis [B. infantis] EVC001), a probiotic manufactured by Infinant Health. The product contains 8 billion colony-forming units suspended in medium-chain triglycerides oil per 0.5 mL, the labeled serving size. It is available in a vial that contains a total of 0.7 mL. Although it is intended for resolving gut dysbiosis when given to patients via enteral feeding tubes in neonatal ICUs, the packaging resembles vials used for parenteral injection (see Evivo).
The manufacturer's website provides written instructions (http://www.ismp.org/ext/1055) and a video (http://www.ismp.org/ext/1056) on how to remove the cap, the foil ferrule, and the rubber stopper (see Evivo A) to access the vial's contents with an ENFit syringe. However, if practitioners are unfamiliar with the instructions, they may withdraw the dose using a parenteral syringe and needle, as the product looks like a parenteral medication vial.
In addition, the vial label warning "For Enteral or Oral Use" is not well positioned as it is only visible when the vial is turned to read the back edge of the label (see Evivo B). Whenever a substance meant for one route is placed in packaging more typically used for another, the chance of administering the substance by the wrong route increases.
The ISMP reached out to the company to share concerns about the product. If your organization purchases this product, ensure staff knows the correct preparation and administration instructions. All doses should be prepared in the pharmacy in an ENFit/oral syringe to prevent using a parenteral syringe and administering the drug via the wrong route.