Sufentanil and Bupivacaine Solution Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Sufentanil and Bupivacaine Solution due to FDA inspection findings regarding sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential sterility issues in injectable medications.
Plain-English summary
The Compounding Pharmacy of America is recalling Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution, Sterile=Preservative Free. The product is a 43 ml sterile solution distributed nationwide. 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 that potentially impact product quality and sterility. The agency classified this as a Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Sufentanil 45 mcg/ml + Bupivacaine 5 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 (2)
- All lots distributed between November 2014 and May 2015 04142015@70
- 7/13/2015
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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