Pharmakon Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a sterile product) map to a score of 4 (Severe), as Class I is required for a score of 5.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 100 units of Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringes. The recall is being conducted due to a lack of assurance of sterility for the sterile compounded products.
The affected products are prescription-only (Rx Only) and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana. The recall covers all sterile compounded products within their expiry dates. The distribution pattern is listed as nationwide, with specific mentions of VA/DOD locations in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Healthcare providers and patients should discontinue use of the recalled syringes and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 100
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.
See all 88 products in this recall →Related recalls
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