Over 2 Million Syringes, IV Bags Recalled for Lack of Sterility Assurance

More than 2.1 million syringes and IV bags containing various compounds for injection were recalled due to a lack of sterility assurance.

The recalls were issued voluntarily by Nephron Sterile Compounding Center LLC on May 18, 2022. The US Food and Drug Administration designated the recalls Class II on May 27, 2022, which indicates use of the recalled compounds may result in temporary or medically reversible adverse effects, or a remote possibility of serious complications.

The recalls affect the following products, which were distributed by Nephron’s 503B outsourcing facility in West Columbia, South Carolina:

• 8.4% sodium bicarbonate injection, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL prefilled syringes, packaged in 10 x 1 and 30 x 1 syringe cartons (NDC: 69374-214-50), from lots SB2001A (Exp. 1/2/2023); SB2005B and SB2005C (Exp. 3/8/2023); SB2006A, SB2006B, and SB2006C (Exp. 3/16/2023);
• calcium gluconate injection, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL and 5 x 10 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-950-10), from lots CG1003A (Exp. 12/3/2022) and CG2001A (Exp. 2/10/2023);
• EPINEPHrine injection, 0.1 mg/10 mL (10 mcg/mL), 10 mL and 5 x 10 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-544-10), from lots EN2005A (Exp. 7/25/2022); EN2009A (Exp. 8/20/2022); and EN2010A (Exp. 9/13/2022);
• epinephrine injection, 1 mg/10 mL (100 mcg/mL), 10 mL and 5 x 10 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-925-10), from lots EN1047A (Exp. 6/7/2022); EN2002A (Exp. 7/7/2022); EN2006A (Exp. 7/19/2022); and EN2011A (Exp. 9/1/2022);
• fentanyl citrate in 0.9% sodium chloride injection, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV bag, 10 x 1 IV bags (NDC: 69374-523-21), from lots FN1088A (Exp. 6/21/2022) and FN1089A (Exp. 6/26/2022);
• glycopyrrolate injection, 1 mg/5 mL (0.2 mg/mL), preservative free, 5 mL and 5 x 5 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-903-05), from lot GL2002B (Exp. 8/13/2022);
• glycopyrrolate injection, 0.6 mg/3 mL (0.2 mg/mL), preservative free, 3 mL and 5 x 3 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-903-03), from lot GL2002A (Exp. 8/13/2022);
• hydromorphone HCl injection, 50 mg/50 mL (1 mg/mL), 50 mL and 5 x 50 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-559-50), from lot HN2005A (Exp. 9/17/2022);
• hydromorphone HCl injection, 6 mg/30 mL (0.2 mg/mL), 30 mL and 5 x 30 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-529-30), from lot HH2008A (Exp. 9/5/2022);
• ketamine hydrochloride injection, 30 mg/3 mL (10 mg/mL), 3 mL and 5 x 3 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-982-33), from lot KH2008A (Exp. 8/8/2022);
• ketamine hydrochloride injection, 50 mg/5 mL (10 mg/mL), 5 mL and 5 x 5 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-982-55), from lots KH1086A (Exp. 6/24/2022); KH2002B (Exp. 7/5/2022); KH2008B (Exp. 8/8/2022); and KH2012A (Exp. 8/23/2022);
• labetalol HCl injection, 20 mg/4 mL (5 mg/mL), preservative free, 4 mL and 5 x 4 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-946-04), from lots LB1020A and LB1022A (Exp. 5/21/2022); LB2003A (Exp. 8/5/2022); and LB2007A (Exp. 9/20/2022);
• lidocaine HCl injection, 2%, 100 mg/5 mL (20 mg/mL), preservative free, 5 mL and 5 x 5 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-949-05), from lot LI2001A (Exp. 6/8/2022);
• neostigmine methylsulfate injection, 5 mg/5 mL (1 mg/mL), preservative free, 5 mL and 5 x 5 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-902-05), from lots NE2001A (Exp. 6/30/2022) and NE2009B (Exp. 8/27/2022);
• oxytocin 30 units/500 mL (0.06 units/mL) in 0.9% sodium chloride injection, 500 mL single-dose container bag, 10 x 1 IV bag (NDC: 69374-543-50), from lots OX2008C (Exp. 5/27/2022); OX2010C (Exp. 6/17/2022); OX2011C and OX2011D (Exp. 6/24/2022);
• phenylephrine HCl injection, 0.4 mg/10 mL (40 mcg/mL), 10 mL and 5 x 10 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-955-10), from lots PE1108A (Exp. 5/27/2022); PE2006A (Exp. 8/3/2022); and PE2010A (Exp. 8/12/2022);
• phenylephrine HCl injection, 0.8 mg/10 mL (80 mcg/mL), 10 mL and 5 x 10 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-956-10), from lots PE1107A (Exp. 5/22/2022); PE1123A (Exp. 6/21/2022); PE2007A (Exp. 8/4/2022); and PE2012A (Exp. 8/28/2022);
• phenylephrine HCl injection, 1 mg/10 mL (100 mcg/mL), 10 mL and 5 x 10 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-957-10), from lots PE1115B and PE1115C (Exp. 5/31/2022); PE1122A (Exp. 6/19/2022); PE2004B and PE2004C (Exp. 7/11/2022); PE2011A and PE2011C (Exp. 8/22/2022); PE2015A, PE2015B, and PE2015C (Exp. 9/5/2022); and PE2016A, PE2016B, and PE2016C (Exp. 9/13/2022);
• rocuronium bromide injection, 50 mg/5 mL (10 mg/mL), preservative free, 5 mL and 5 x 5 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-924-05), from lots RC1050A (Exp. 5/30/2022); RC1051B (Exp. 6/6/2022); RC1053A (Exp. 6/27/2022); RC2001A (Exp. 7/19/2022); RC2002A (Exp. 8/13/2022); RC2003A (Exp. 8/28/2022); and RC2004A (Exp. 9/8/2022); and
• succinylcholine chloride injection, 100 mg/5 mL (20 mg/mL), preservative free, 5 mL and 5 x 5 mL prefilled syringes, packaged in 6 x 5 syringe cartons (NDC: 69374-920-05), from lots SU2004A (Exp. 5/18/2022) and SU2007A (Exp. 6/2/2022).