Hospira issues nationwide recall of Dobutamine Injection due to presence of visible particulates

Hospira Inc. has issued a voluntary nationwide recall of one lot of Dobutamine injection, USP, 250 mg, 20 ml, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. The NDC and lot number can be found on the right-hand side of the primary label. The recall is at user level.

The recall was initiated due to the customer report of discolored solution. During the evaluation of the complaint, a chip in the glass at the neck of the vial was identified as well as glass particulate within the solution. And the discoloration of the solution may have resulted either from contamination of the solution or more likely, oxidation, as dobutamine is oxygen sensitive. The presence of particulate matter or glass possess the risk for particulate to be injected, a breach of sterility/contamination of the vial contents, leakage of contents, and/or a delay in therapy.

Generally, the injected particulate matter can result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. The obstruction of small capillaries can also occur. Moreover the leakage of content will leads to loss of sterility. And if further this contaminated solution is used for the patients, it may potentially cause bacteremia, sepsis, septic shock and endocarditis, and death may result. Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting.

The company was unable to determine the root cause, but recalled the entire lot as a precautionary measure. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.