Pharmakon Recalls Hydromorphone Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.
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 compounded drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 10 units of Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes (grey). The recall is being conducted because the company lacks assurance of the sterility of these sterile compounded products.
The affected products are identified by NDC 45183-0504-41 and are distributed nationwide, including 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 cadd cassettes and contact Pharmakon Pharmaceuticals or their local FDA office for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Sterile Drug
- Hazard
- Affected units
- 10
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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