FDA Drug recall D-0962-2018
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag
- FDA Drug
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag by Avella Of Deer Valley Store 38, citing lack of Assurance of Sterility: Potential leakage of bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0962-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-12 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avella Of Deer Valley Store 38 |
| Distribution | US |
Product
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
Reason
Lack of Assurance of Sterility: Potential leakage of bags.
Identifiers
| code_info | Lot #: 5/22/18 1012 495-89425P, BUD 7/21/2018; 6/5/18 0302 495-89425P, BUD 8/4/2018. . |
|---|
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-0962-2018%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.