FDA Recalls Morphine, Clonidine, and Bupivacaine Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a sterile solution containing morphine, clonidine, and bupivacaine because an FDA inspection found 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 source text explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
The Compounding Pharmacy of America is recalling 43 ml vials of Morphine 50 mg/ml + Clonidine 500 mcg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free. The product was distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this as a Class II recall.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for further instructions.
The recalled product
- Product
- Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable 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 (3)
- All lots distributed between November 2014 and May 2015
- 04012015@6
- 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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