Extended Use Dates to Address Sterile Water for Injection Shortage

Due to intermittent supply interruptions of sterile water for injection, on October 11, 2018, the FDA alerted health care professionals and patients of updated dates through which some sterile water for injection manufactured by Hospira, a Pfizer company, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.


Stability data provided by Pfizer and reviewed by the FDA supported extended use dates for specific batches of sterile water for injection. Patients who have the specified batch numbers will be able to use them through the corresponding new use dates to help with supply. As data become available, the list may continue to expand.


The FDA did not require or recommend that the identified batches be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the FDA expected the specified lots will be replaced and properly disposed of as soon as possible.


See the FDA Drug Shortages Announcement


See also Medical Risk Law Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication