Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 50 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
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 and involves a lack of assurance of sterility in a compounded drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 50 bags of Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL Intravia bags. The recall is being conducted because of a lack of assurance of sterility for these sterile compounded products.
The affected products are prescription-only and were distributed nationwide, as well as to VA/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 products and contact Pharmakon Pharmaceuticals for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Sterile Drug
- Affected units
- 50
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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