Pharmakon Recalls Bupivacaine HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Bupivacaine HCI 0.125% bags due to a lack of assurance of sterility. The recall affects 55 units distributed nationwide.
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 associated with non-sterile medical products.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 55 units of Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL Intravia bags. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0909-02. The recall is being conducted due to a lack of assurance of sterility.
The affected products were distributed nationwide, with specific distribution 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.
Consumers and healthcare providers should stop using the affected product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. No specific lot numbers or dates are provided in the source text, so users should verify product details against the NDC and manufacturer information.
The recalled product
- Product
- Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 55
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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