Hospira Recalls Lots of Five Injections as FDA Re-Inspection Continues
Customers said three lots of its diazepam injection, furosemide injection, and Quelicin succinylcholine chloride injections had “either a loose crimp or no crimp” applied to the “flip top vial and in one instance the stopper came out when attempting to remove the flip top cap of the vial,” according to Hospira.
This could result in a breach of sterility, contamination including bacteria, virus, fungi and particulate, or leakage of contents. A leakage of furosemide “has the potential to be irritating to the eyes and the respiratory tract,” while if diazepam “comes into contact with skin or eyes there is the potential for a sedating effect,” Hospira said.
The company is also recalling three lots of its propofol injectable emulsion “due to visible particles embedded in the glass identified during a retain sample inspection.” There may be the potential for product to come into contact with the particles, which also may become dislodged into the solution, according to Hospira. The recall of propofol may also worsen a shortage of the injectable that was recently highlighted last week by the American Society of Health-System Pharmacists.
In addition, one lot of preservative-free morphine sulfate injection is being recalled due to reports where either a loose crimp or no crimp was applied to the flip top vial.
The company noted that due to the crimp issues, it is “possible the vial could be used by a clinician without realizing the product may not be sterile and this has the potential of an infectious agent to be injected into a patient.” However, there have not been any reports of adverse events for any of the recalled lots.
Previous Recalls
The recalls announced Monday and Tuesday follow just a week after the recall of one lot of its 0.9% Sodium Chloride injection, due to “the product lot being incorrectly released without meeting product specifications,” and one lot of its metronidazole injection “due to the potential for solution to leak from the administrative port to the fill tube seal.”
Meanwhile, almost two weeks ago, the FDA began its re-inspection of the company’s Rocky Mount, N.C. manufacturing facility, which CEO Michael Ball said in its fourth-quarter earnings call could be “extensive and lengthy.”
The North Carolina plant where Hospira manufactures its propofol was shut down last year but reopened after it claimed to have fixed the problems. Ball said in the call that the company hoped to relaunch the plant in early 2013.
Hospira did not respond to a request for comment on which manufacturing facilities produced the recently recalled lots.
