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.
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 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
- 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 →- SevereAmerita Recalls Baclofen and Clonidine Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-01-27
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
Similar recalls
- SevereAssurance Infusion Recalls Baclofen Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Baclofen and Fentanyl Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Baclofen, Clonidine, and Morphine Syringes for Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Baclofen and Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereBaclofen Intrathecal Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23