Morphine Solution Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Morphine 15 mg/ml 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 agency classification is FDA Class II, and the source text explicitly states that GMP violations potentially impact product quality and sterility, which aligns with the rubric criteria for Severe severity involving significant quality risks.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 15 mg/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 03162015@54 and 04222015@14.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, resulting in a lack of assurance of sterility.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Morphine 15 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 (5)
- All lots distributed between November 2014 and May 2015
- 03162015@54
- 6/14/2015
- 04222015@14
- 7/21/2015
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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