FDA Drug recall D-0569-2016
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
- FDA Drug
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 by Amerita Specialty Infusion Services, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0569-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-24 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amerita Specialty Infusion Services |
| Distribution | AZ |
Product
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot # 112621/E; Exp 12/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0569-2016%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.