Pharmakon Recalls Hydromorphone Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 12 units of Hydromorphone HCl 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a sterile product where sterility assurance is lacking is categorized as Severe (Score 4), as it poses a risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 12 units of Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey). The recall is being conducted because of a lack of assurance of sterility for the compounded product. The affected product is identified by NDC 45183-0114-48 and includes all sterile compounded products within their expiry dates.
The recalled product was distributed nationwide as well as to specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The FDA 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 affected product and contact Pharmakon Pharmaceuticals for further instructions or a replacement. Consumers should not use the product if they have questions about its sterility or safety.
The recalled product
- Product
- Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 12
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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