Drug Safety Alerts

0.9% NaCl Injection Consumer-Level Recall

2/25/2022

On February 25, 2022, B Braun issued a consumer-level recall of the flexible container-excel product 0.9% NaCl Injection, 250 mL NDC #00264-7800-20 manufactured by B Braun. This recall was issued due to reports of fluid leakage or low fill volume of the respective containers. There is also the potential for smaller micro-leaks which may not be readily identified by the user.

The above may represent a potential health hazard or safety risk to patients using product affected by this recall.

A complete list of the affected lots can be found here.

Potential leakage of hazardous medication may lead to acute exposure to patients, users, or third parties. Unidentified leakage could lead to contamination with microorganisms causing the potential for bloodstream infection from product usage which could become a life-threatening event.

B Braun recommends that patients should not use flexible container-excel 0.9% NaCl Injection, 250 mL that is affected by this recall.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking flexible container-excel 0.9% NaCl Injection, 250 mL to contact their prescriber.

For more information about the recall, please call B Braun toll-free at 1-833-425-1464. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.