Morphine and Clonidine Solution Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings regarding 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, which corresponds to the 'Severe' severity level in the rubric, particularly given the risk of sterility failure in a sterile injectable medication.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free. The recall involves 86 ml total volume units distributed nationwide between November 2014 and May 2015. Specific lot codes include 02272015@33 and 04012015@3.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency cited a lack of assurance of sterility as the primary reason for the action.
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.
The recalled product
- Product
- Morphine 50 mg/ml + Clonidine 100 mcg/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 (5)
- All lots distributed between November 2014 and May 2015
- 02272015@33
- 5/28/2015
- 04012015@3
- 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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