Baclofen Intrathecal Solution Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Baclofen 1,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable/intrathecal products are categorized as Severe (Score 4) due to the risk of infection, even if specific hospitalization reports are not yet detailed in the source text.
Plain-English summary
The Compounding Pharmacy of America is recalling Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free. The product is a 22 mL total volume solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically identified by the code 04272015@23, 7/26/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the solution is sterile.
Patients and healthcare providers who have received or are using this specific product should contact their healthcare provider for guidance on next steps. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Intrathecal Solution
- Hazard
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 (3)
- All lots distributed between November 2014 and May 2015
- 04272015@23
- 7/26/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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.
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