The affected products contain Lot #59277EV (Exp 1Nov2017), #60028EV (Exp 1Dec2017), and #60082EV (Exp 1Dec2017). They are supplied as 10 ampule per tray and 100 ampules per case. Hospira stated the potential risk of patient harm is deemed low since the defective vials are readily identifiable.
Fentanyl Citrate Injection, an opioid, is indicated as short-term analgesia during anesthetic periods, premedication, induction and maintenance; and in the immediate postoperative periods as need arises; as an analgesic supplement in general or regional anesthesia; concomitantly with neuroleptic (eg, droperidol) as an anesthetic premedication, for anesthesia induction and as an adjunct in the maintenance of general and regional anesthesia; and as an anesthetic in combination with oxygen in selected high risk patients (eg, undergoing open heart surgery, complicated neurological or orthopedic procedures). Fentanyl Citrate is used for intravenous (IV) or intramuscular (IM) use.
Distributors should further notify those who may have received the recalled product.