Morphine and Clonidine Solution Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings of GMP violations affecting 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 sterility assurance for an injectable medication, which poses a significant risk of serious injury (e.g., infection) if administered, fitting the 'Severe' criteria for significant injury risk.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free. The product was distributed nationwide in 66 ml volumes. The recall covers all lots distributed between November 2014 and May 2015, specifically identified by codes 03092015@11, 03302015@7, and 4242015@50.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, meaning there is a lack of assurance that the solution is sterile.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Morphine 20 mg/ml + Clonidine 500 mcg/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 (7)
- All lots distributed between November 2014 and May 2015
- 03092015@11
- 6/7/2015
- 03302015@7
- 6/28/2015
- 4242015@50
- 7/23/2015
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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