FDA Recalls Compounded Sterile Morphine, Fentanyl, and Bupivacaine Solution
The Compounding Pharmacy of America is recalling a sterile compounded solution of morphine, fentanyl, and bupivacaine due to GMP violations that compromise 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 recall is classified as FDA Class II and involves a sterile injectable product where GMP violations compromise sterility assurance, posing a significant risk of serious injury or death from infection.
Plain-English summary
The Compounding Pharmacy of America is recalling a sterile, preservative-free solution containing morphine, fentanyl, and bupivacaine. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a compounded sterile solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring in June 2015.
Healthcare providers and patients should stop using the recalled product immediately. The lack of assurance of sterility poses a risk of infection or other adverse health consequences if the product is administered. Users should contact the recalling firm or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
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
- 03092015@15
- 6/7/2015
- 04092015@69
- 6/8/2015
- 05012015@12
- 6/30/2015
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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