Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 bags of compounded Fentanyl Citrate and Ropivacaine HCI 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, and the hazard involves a lack of assurance of sterility in a compounded drug, which poses a risk of serious injury or hospitalization.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 20 bags of Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL. The recall is being conducted because of a lack of assurance of sterility for the sterile compounded products.
The affected product is identified by NDC 5183-0906-48 and includes 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.
Consumers and healthcare providers should stop using the affected product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Sterile Drug
- Affected units
- 20
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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