Drug Safety Alerts

8.4% Sodium Bicarbonate Injection 50 mEq single-dose vials Class I Recall

04/10/2019

On April 10, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall 8.4% Sodium Bicarbonate Injection 50 mEq single-dose vials NDC # 00409-6625-02 manufactured by Hospira, Inc. This recall was issued because of the presence of particulate matter, confirmed as glass. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

This recall affects lot numbers 80-088-EV exp. 08/01/19, 79-240-EV exp. 07/01/19 and 79-238-EV exp. 07/01/19.

Please note: This recall was originally issued on March 18, 2019 to the hospital/institutional level. The FDA classified this as a Class I recall on April 10, 2019.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using 8.4% Sodium Bicarbonate Injection 50 mEq single-dose vials to contact their prescriber.

For more information about this recall, please contact Pfizer Medical Information at 1‑800‑438‑1985 option 3, Monday through Friday, 8:00 am – 7:00 pm (ET). You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.