Vehicle Safety Product Safety Food Safety Pet Safety Drug Safety Device Safety Workplace Safety

Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, I...

FDA Recall #D-0569-2016 — Class II — December 24, 2015

Recall #D-0569-2016 Date: December 24, 2015 Classification: Class II Status: Terminated

Product Description

Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Amerita Specialty Infusion Services — Prescott, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1 syringe

Distribution

AZ only. No foreign distribution.

Code Information

Lot # 112621/E; Exp 12/15

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

Back to All Drug Recalls