Morphine and Bupivacaine Solution Recalled for Sterility Assurance Issues
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine Solution due to FDA inspection findings of GMP violations that 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 recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, particularly given the risk of sterility failure in a sterile injectable product.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free. The product is a 43 ml sterile solution manufactured in Knoxville, TN, and was distributed nationwide.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. This lack of assurance of sterility poses a risk to patients using the medication.
All lots distributed between November 2014 and May 2015 are affected. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Solution
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
- 03162015@6
- 6/14/2015
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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