FDA Drug recall D-0460-2018
Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging
- FDA Drug
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging by Pharmedium Services, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0460-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-27 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Reason
Lack of sterility assurance.
Identifiers
| code_info | All lots remaining within expiry. |
|---|
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-0460-2018%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.