PlainRecalls
FDA Drug Moderate Class II Terminated

HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30

Reported: July 27, 2022 Initiated: June 30, 2022 #D-1257-2022

Product Description

HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
18,570 syringes
Distribution
Nationwide in the USA
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 18,570 syringes.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on July 27, 2022. Severity: Moderate. Recall number: D-1257-2022.