Morphine and Fentanyl Solution Recalled Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine and Fentanyl solution because FDA inspections found GMP violations that may affect 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free. The recall is being conducted because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product is an 86 ml total volume solution. All lots were distributed nationwide between November 2014 and May 2015. Specific lot codes include 04142015@73 with an expiration date of 7/13/2015, and 03162015@65 with an expiration date of 6/14/2015.
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 + Fentanyl 2,000 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 (5)
- All lots distributed between November 2014 and May 2015
- 04142015@73
- 7/13/2015
- 03162015@65
- 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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