IT Custom Compound — Class II drug recall D-0570-2016
Terminated recall by Amerita Specialty Infusion Services, reported 2016-01-27, distributed in AZ. Lack of Assurance of Sterility
| Recall number | D-0570-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerita Specialty Infusion Services, Prescott, AZ, United States |
| Recall initiated | 2015-12-24 |
| Classified | 2016-01-15 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-02-10 |
| Distributed | AZ |
| Quantity | 1 syringes |
| Reason classes | sterility |
| Lot numbers | 10/15, 112621/E |
Product
IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0570-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.