BETHESDA, MD 27 Dec 2013—On December 23, Hospira Inc. and Baxter International Inc. announced recalls of select lots of sterile products because particulate matter had been found on or in the solutions.
Hospira (PDF) is recalling lidocaine hydrochloride lot 32-135-DD, which consists of 5-mL single-dose vials of 2% lidocaine hydrochloride injection with an expiration date of August 1, 2015.
The company said a reddish orange particulate, possibly containing iron, was found "on the inner surface and floating in the solution." If the particulate does contain iron, the company said, infusion of the solution could put a patient at risk for local inflammation and tissue trauma when undergoing magnetic resonance imaging. The particulate is believed by the company to be related to a defect in the glass vials provided by a supplier.
Hospira said lidocaine hydrochloride lot 32-135-DD was distributed to hospitals, pharmacies, and wholesalers in 28 states in September and October 2013.
Anyone with vials from the lot is being told to quarantine the vials and return them to Stericycle. Hospira said it will notify its direct customers and distributors about the recall and arrange for return of vials in lot 32-135-DD to Stericycle. Additional assistance can be obtained by calling Stericycle at 855-695-8596 between 8 a.m. and 5 p.m. ET, Monday through Friday.
Baxter (PDF) is recalling 5% dextrose injection lot P285288 and 0.9% sodium chloride injection lots P292326, P293514, P293993, and P297283. These lots consist of 50- or 100-mL flexible plastic containers with an expiration date of November 2013 or April, May, or August 2014.
The company said particulate matter was found in solutions from those lots.
Baxter said products in those lots were distributed to health care centers and distributors in the United States and elsewhere between May 2012 and October 2013.
Anyone with products from the five lots is being told to stop using those products and return them to Baxter for credit. Returns are to be arranged by calling the company's Center for Service at 888-229-0001 between 7 a.m. and 6 p.m. CT, Monday through Friday. Baxter said replacements are available from lots that are not part of the recall.