Bupivacaine Intrathecal Solution Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injuries are reported, the lack of sterility assurance in an intrathecal (spinal) injection product represents a significant risk of harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the hazard is significant (Class II).
Plain-English summary
The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free. The product is available in 22 mL quantities. The recall covers all lots distributed between November 2014 and May 2015, including lot 03092015@3 dated 6/7/2015. The distribution pattern is nationwide.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific concern cited is a lack of assurance of sterility for the intrathecal solution.
Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The source text does not specify a particular action for consumers beyond the general recall notice, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Anesthetic
- 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
- 03092015@3
- 6/7/2015
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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