Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable products are classified as Severe (Score 4) due to the significant risk of infection, even without reported hospitalizations in the text.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free. The product is a 44 ml total volume solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically lot 03022015@85 with an expiration date of 5/31/2015, and lot 03202015@76 with an expiration date of 6/18/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, creating a lack of assurance that the product is sterile.
Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/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 (5)
- All lots distributed between November 2014 and May 2015
- 03022015@85
- 5/31/2015
- 03202015@76
- 6/18/2015
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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