Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.
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 a parenteral medication, which poses a significant risk of serious injury or death from infection.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 100 vials of HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial. The recall is being conducted due to a lack of assurance of sterility for the sterile compounded products.
The affected product is identified by NDC 45183-0702-68 and is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana. The recall covers all sterile compounded products within their expiry dates.
The product was distributed nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 100
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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