FDA Drug recall D-0028-2023
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- FDA Drug
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 by Pharmacy Plus, citing lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0028-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-07 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmacy Plus |
| Distribution | AL, LA, MS, TN |
Product
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Identifiers
| code_info | Lots: 65521, BUD: 10/15/2022; 65545, BUD: 10/15/2022; 65605, BUD: 10/16/2022; 65658, BUD: 10/17/2022; 65733, BUD: 10/21…Lots: 65521, BUD: 10/15/2022; 65545, BUD: 10/15/2022; 65605, BUD: 10/16/2022; 65658, BUD: 10/17/2022; 65733, BUD: 10/21/2022; 65894, BUD: 10/24/2022; 66019, BUD: 10/28/2022; 66120, BUD: 10/30/2022; 66388, BUD: 11/6/2022; 66755, BUD: 11/14/2022; 66870, UD: 11/18/2022; 66928, BUD: 11/19/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0028-2023%22
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