FDA Drug recall D-0323-2022
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1…
- FDA Drug
- Class II
- terminated
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1… by Sterrx, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0323-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-12 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sterrx |
| Distribution | US |
Product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | S21087/BQX 16-Dec-21 S21151/BTJ 24-Jan-22 S21186/BUQ 14-Feb-22 S21189/BUS 16-Feb-22 S21266/BXJ 3-Apr-22 S21307/BYW 24-Apr-22 S21313/BZC 27-Apr-22 |
|---|
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-0323-2022%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.