PlainRecalls
FDA Drug Moderate Class II Terminated

Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10

Reported: July 27, 2022 Initiated: June 30, 2022 #D-1245-2022

Product Description

Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
163 bags
Distribution
Nationwide in the USA
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 163 bags.
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-1245-2022.