The Recall Desk
SevereFDA (Drugs)·D-0569-2016·Announced 2016-01-27

Amerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns

Amerita Specialty Infusion Services is recalling specific lots of compounded Baclofen syringes because the FDA identified a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies a 'Lack of Assurance of Sterility' for a drug intended for intrathecal use. Under the severity rubric, a lack of sterility assurance for a drug administered directly into the spinal fluid constitutes a significant injury risk, warranting a score of 4 (Severe) even in the absence of reported hospitalizations.

Plain-English summary

Amerita Specialty Infusion Services is recalling Baclofen 1 mg/ml in 40 ml NS syringes, compounded for intrathecal use only. The recall is being conducted because the U.S. Food and Drug Administration identified a lack of assurance of sterility for the affected product.

The specific product affected is Lot # 112621/E with an expiration date of 12/15. The recall is limited to distribution within the state of Arizona, with no foreign distribution reported.

Patients who have received this medication should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Manufacturer
Amerita Specialty Infusion Services
Category
Drug — Compounded Sterile Preparations
Hazard
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 12/15

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 →

Related recalls

Same manufacturer · Amerita Specialty Infusion Services

See all →

Same hazard · infection

See all →