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

FDA recall notice · announced January 27, 2016 · Amerita Specialty Infusion Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: AZ only. No foreign distribution.
Lot/code information: Lot # 112621/E; Exp. 10/15
Quantity: 1 syringe
Status: Terminated
Products in this recall event:
- Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 (D-0569-2016)
- 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 (D-0570-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.