Multi-event December 2015 FDA Recall Drug by Amerita Specialty Infusion Services

This Multi-event Class II drug recall was voluntarily initiated by Amerita Specialty Infusion Services on December 24, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in AZ only. No foreign distribution. and the recall is currently terminated.

Reported Recall Events

D-0570-2016 TERMINATED D-0569-2016 TERMINATED

Recall Number: D-0570-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-24-2015
Reported
01-27-2016
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amerita Specialty Infusion Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ only. No foreign distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# 112621/E; Exp. 10/15

Recall Number: D-0569-2016

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-24-2015
Reported
01-27-2016
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72967
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amerita Specialty Infusion Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ only. No foreign distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2016
Product Description About Product Description
Full technical description of the product.
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

Batch or Lot Expiration Information

Lot# 112621/E; Exp 12/15