Morphine Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Morphine 20 mg/ml Solution because FDA inspections 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which aligns with the 'Severe' criteria for significant potential harm.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 20 mg/ml Solution, Sterile-Preservative Free. The product was distributed nationwide in 235 ml volumes. The recall covers all lots distributed between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the solution is sterile.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for instructions on return or disposal. The recall number is D-1588-2015.
The recalled product
- Product
- Morphine 20 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 (14)
- All lots distributed between November 2014 and May 2015
- 03122015@98
- 6/10/2015
- 03162015@57
- 6/14/2015
- 03162015@79
- 04062015@42
- 7/5/2015
- 05042015@4
- 7/2/2015
- 05042015@69
- 7/3/2015
- 05122015@17
- 7/11/2015
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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