Agency classClass IIOur severity:Severe FDA (Drugs)·D-0570-2016·Announced 2016-01-27

Amerita Recalls Baclofen and Clonidine Syringes Due to Sterility Concerns

Amerita Specialty Infusion Services is recalling specific lots of compounded intrathecal syringes because the company cannot ensure they are sterile.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a product intended for intrathecal use, which carries a significant risk of serious injury or infection.

Plain-English summary

Amerita Specialty Infusion Services is recalling IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringes. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is compounded by Amerita, Inc., located in Prescott, AZ, and is intended for intrathecal use only.

The recall involves Lot # 112621/E with an expiration date of 10/15. The distribution was limited to Arizona, with no foreign distribution reported. The product is a prescription-only medication.

Consumers and healthcare providers who have this specific lot of the product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

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
Manufacturer: Amerita Specialty Infusion Services
Category: Drug — Compounded Prescription
Hazard: sterility
infection
Affected units: 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # 112621/E
Exp. 10/15

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Amerita Specialty Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Amerita Specialty Infusion Services

See all →

Severe
Amerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-01-27

Same hazard · sterility