Analgesic Injections Recalled

Nephron Sterile Compounding Center is recalling more than 50,000 syringes containing hydromorphone hydrochloride injection because of a lack of assurance of sterility, according to the July 27, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• hydromorphone hydrochloride injection, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30-mL prefilled syringes per carton, 6 x 5 syringe cartons per case (NDC 69374-529-30), from lots HH2003A (Exp. 7/26/22) and HH2006A (Exp. 8/22/22);
• hydromorphone hydrochloride injection, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50-mL prefilled syringes per carton, 6 x 5 syringe cartons per case (NDC 69374-529-50), from lots HH2002A (Exp. 7/7/22), HH2004A (Exp. 8/28/22), HH2005A (Exp. 8/11/22), HH2007A (Exp. 9/2/22), HH2009A (Exp. 9/10/22), and HH2011A (Exp. 10/17/22);
• hydromorphone hydrochloride injection, 30 mg/30 mL (1 mg/mL) syringes, 5 x 30-mL prefilled syringes per carton, 6 x 5 syringe cartons per case (NDC 69374-559-30), from lots HN2001A (Exp. 7/23/22), HN2003A (Exp. 8/19/22), and HN2004A (Exp. 9/9/22); and
• hydromorphone hydrochloride injection, 50 mg/50 mL (1 mg/mL) syringes, 5 x 50-mL prefilled syringes per carton, 6 x 5 syringe cartons per case (NDC 69374-559-50), from lot HN2002A (Exp. 7/26/22).

Nephron Sterile Compounding Center voluntarily initiated the recalls June 30, 2022. On July 18, 2022, the FDA designated them Class II. The recall designation signals that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Hydromorphone hydrochloride injection is a prescription medication used to relieve moderate to severe pain.