Confirmed consumer reports of visible stainless steel and iron oxide (rust) particles prompted HOSPIRA, INC. to announce voluntary recalls on July 12 and August 29, 2013, for one lot of 0.25% Bupivacaine HCI Injections and one lot of 0.75% Bupivacaine HCl Injections. Bupivacaine is injected in a wide variety of surgical, dental, oral, diagnostic, therapeutic, and obstetric procedures for both anesthesia and analgesia (pain block).
Particulates may block the physical administration of the drug, preventing the anticipated treatment. Particulates that are actually injected expose patients to serious risks, including: thrombophlebitis, bacterimia, sepsis, endocarditis, and even death. Potential signs and symptoms include:
- Redness
- Pain
- Swelling at the injection site
- Fever
- Dyspnea (shortness of breath)
- Tachycardia (heart rate exceeds normal range)
- Nausea
- Vomiting
On August 30, 2013, Hospira announced a voluntary recall of one lot of its Aminosyn™ II due to a confirmed customer report of human hair in the injection port. For total parenteral nutrition (TPN), Aminosyn II is combined with dextrose, electrolytes, trace elements, vitamins, and fat emulsion. If foreign particulate passes through the intravenous catheter or an intravenous infusion, it could cause local inflammation, phlebitis (inflammation of the veins), capillary blockage, and/or an allergic response. Patients with preexisting trauma or any other medical condition in which the microvascular blood supply is compromised are at an increased risk.
The following Hospira injectables have been recalled:
- 0.25% Bupivacaine HCl Injection (2.5 mg/mL)
- 30 mL single-dose vial
- NDC#: 0409-1159-02
- 0.75% Bupivacaine HCl Injection (7.5 mg/mL)
- 30 mL single-dose vial
- NDC#: 0409-1165-02
- Aminosyn II 10%, Sulfite-Free
- 500 mL
- Lot#: 26-138-JT (may be followed by “01”)
- Expiration: 08/01/2014
We encourage patients and loved ones who have been affected by Hospira’s contaminated injections or parenteral products to contact us for a free case evaluation at www.andrewsthornton.com or toll free at 1-800-644-1734.
