Pharmakon Recalls Ropivacaine HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 129 bags of Ropivacaine HCI 0.2% due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the risk is significant.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 129 bags of Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL Intravia bag. 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 45183-0942-03 and includes all sterile compounded products within their expiry dates.
The recalled product was distributed nationwide as well as to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The agency 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.
Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals for further instructions or a replacement. Consumers should not use the product if they have any questions regarding its sterility or safety.
The recalled product
- Product
- Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 129
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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