FDA Drug recall D-0150-2020
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl
- FDA Drug
- Class II
- terminated
- Published 2019-10-30
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-0150-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-09 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Pharmaceuticals |
| Distribution | US |
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_info | Lots: 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
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