FDA Recalls Compounded Morphine and Fentanyl Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded 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 involves a lack of assurance of sterility in a compounded injectable medication, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant harm).
Plain-English summary
The Compounding Pharmacy of America is recalling a sterile, preservative-free solution containing morphine, fentanyl, baclofen, and clonidine. The product was distributed nationwide in 129 ml quantities between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. This lack of assurance of sterility poses a risk to patients using the medication.
Consumers and healthcare providers should stop using the affected product immediately. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
- 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
- 02252015@12
- 5/20/2015
- 03242015@80
- 6/22/2015
- 04222015@24
- 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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