Fentanyl Intrathecal Solution Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Fentanyl 500 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.
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 agency classification is FDA Class II. The rubric specifies that FDA Class II recalls with potential for serious harm (such as sterility failure in an intrathecal drug) align with the 'Severe' category, particularly given the lack of assurance of sterility which poses a significant risk of infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free. The product is a 23 ml total volume 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. These violations potentially impact the quality and sterility of the product, creating a lack of assurance of sterility.
Healthcare providers and patients should stop using the recalled product. The source text does not specify specific actions for consumers beyond the recall notice itself, but standard protocol for drug recalls involves contacting the manufacturer or a healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable / Intrathecal
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 (3)
- All lots distributed between November 2014 and May 2015
- 04172015@24
- 6/16/2015
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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