October 31, 2019
Nephron Pharmaceuticals Corporation, also known as Nephron Sterile Compounding Center, is recalling a number of injections containing fentanyl because of potential glass contamination, according to the October 30, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed throughout the United States:
- fentanyl citrate 2 mcg/mL and bupivacaine HCl 0.0625% in 0.9% sodium chloride injection (500 mcg/156.3 mg)/250 mL (NDC 69374-0525-25) from lots FB9001A (Exp. 10/31/19), FB9001B (Exp. 10/31/19), FB9013A (Exp. 12/8/19), and FB9015A (Exp. 12/14/19);
- fentanyl citrate 2 mcg/mL and bupivacaine HCl 0.125% in 0.9% sodium chloride injection (500 mcg/312.5 mg)/250 mL (NDC 69374-530-25) from lots FB9014A (Exp. 12/9/19) and FB9017A (Exp. 12/16/19); and
- fentanyl citrate 2 mcg/mL and ropivacaine HCl 0.1% in 0.9% sodium chloride injection (400 mcg/200 mg)/200 mL (NDC 69374-526-20) from lot FR9002A (Exp. 12/12/19).
Nephron Pharmaceuticals Corporation initiated the recalls October 9, 2019. The FDA designated them Class II on October 18, 2019, signaling use of the affected injections may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Fentanyl citrate is a narcotic pain reliever. Fentanyl citrate with added bupivacaine or ropivacaine is used as an epidural analgesic.