Pharmakon Recalls Bupivacaine Injection Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 130 bags of Bupivacaine 1mg/mL injection 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 130 bags of Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag (NDC 45183-0019-02). The recall was initiated because of a lack of assurance of sterility for the compounded sterile product.
The affected product was distributed nationwide and 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 recalled product and contact Pharmakon Pharmaceuticals or their local FDA office for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 130
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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