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.
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 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
- 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 →Related recalls
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See all →- SevereAmerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns
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