FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a sterile morphine, bupivacaine, and clonidine solution because an FDA inspection found 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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in a sterile injectable solution, which poses a significant risk of infection or serious injury, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
The Compounding Pharmacy of America is recalling a specific compounded solution containing Morphine 25 mg/ml, Bupivacaine 30 mg/ml, and Clonidine 200 mcg/ml. The product is a sterile, preservative-free solution in 43 ml quantities. The recall covers all lots distributed nationwide between November 2014 and May 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.
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 to take, such as returning the product or seeking immediate medical attention, beyond the general context of a drug recall.
The recalled product
- Product
- Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
- 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
- 03202015@84
- 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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