FDA Recalls Bupivacaine and Baclofen Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Bupivacaine and Baclofen intrathecal solution because FDA inspections found GMP violations that may affect 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an intrathecal product) are rated as Severe (4).
Plain-English summary
The Compounding Pharmacy of America is recalling Bupivacaine 40 mg/ml + Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free. The product was distributed nationwide between November 2014 and May 2015. Specific lot codes include 02232015@27, 3182015@46, and 04242015@45.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, meaning there is a lack of assurance that the medication is sterile.
Healthcare providers and patients who have received this product should contact their healthcare provider for guidance on next steps. The recall is classified as FDA 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
- Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Intrathecal Solution
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 (7)
- All lots distributed between November 2014 and May 2015
- 02232015@27
- 5/24/2015
- 3182015@46
- 6/16/2015
- 04242015@45
- 6/23/2015
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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