Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 870 bags of Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL Intravia bag. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is identified by NDC 45183-0905-48. The recall is being conducted due to a lack of assurance of sterility.
The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.
Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 870
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 (1)
- All Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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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