RecallRadar

FDA Drug recall D-0150-2020

Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl

On 2019-10-30 the FDA classified a Class II recall of Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl by Nephron Pharmaceuticals, citing lack of Assurance of Sterility; bags have potential to leak.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0150-2020
ClassificationClass II
Statusterminated
Initiated2019-10-09
Published2019-10-30
Last updated2026-09-13 11:52 UTC
CompanyNephron Pharmaceuticals
DistributionUS

Product

Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10

Reason

Lack of Assurance of Sterility; bags have potential to leak

Identifiers

code_infoLots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0150-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.