FDA Recalls Sufentanil and Bupivacaine Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine solution because FDA inspections found violations that may have compromised 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. The hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or adverse health consequences if contaminated, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
The Compounding Pharmacy of America is recalling Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free. The product was distributed nationwide in 200 ml quantities. 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. The source text does not specify specific actions for consumers beyond the recall notice, but standard protocol for recalled sterile injectable medications is to discontinue use and consult a healthcare professional.
The recalled product
- Product
- Sufentanil 50 mcg/ml + Bupivacaine 0.25 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 (20)
- All lots distributed between November 2014 and May 2015
- 04212015@27
- 6/2062015
- 02272015@42
- 5/28/2015
- 03112015@3
- 6/9/2015
- 03162015@85
- 6/14/2015
- 03242015@3
- 6/22/2015
- 03302015@63
- 6/28/2015
- 04062015@44
- 7/5/2015
- 04142015@63
- 7/13/2015
- 04212015@28
- 6/20/2015
- and 05072015@8
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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