FDA Drug recall D-0237-2023
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02%…
- FDA Drug
- Class II
- terminated
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02%… 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-0237-2023 |
| 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
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) OPHTHALMIC, 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 | t20221011@25 t20221011@55 t20221020@26 t20221104@44 t20221027@6 20221019@44 t20221026@41 |
|---|
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-0237-2023%22
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