FDA Drug recall D-0201-2023
DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE
- FDA Drug
- Class II
- terminated
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE by Pharmacy Innovations, citing lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0201-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-22 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmacy Innovations |
| Distribution | US |
Product
DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Identifiers
| code_info | t20221116@36 t20221117@11 t20221108@87 |
|---|
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-0201-2023%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.