FDA Recalls Fentanyl and Bupivacaine Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine intrathecal solution because an FDA inspection 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. The hazard involves a lack of assurance of sterility in an intrathecal (spinal) injection, which carries a significant risk of serious injury or infection if the product is contaminated.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution. The product is a sterile, preservative-free solution with a total volume of 22 ml. The recall covers all lots distributed between November 2014 and May 2015, including specific codes 03092015@16 and 6/7/2015.
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. The product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product immediately. Patients should consult their healthcare provider for alternative treatment options. The recalling firm is The Compounding Pharmacy of America, located in Knoxville, TN.
The recalled product
- Product
- Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- 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@16
- 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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