Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 670 vials of compounded Hydromorphone HCl 0.4mg/ml due to a lack of assurance of sterility. The products were distributed nationwide to VA and 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 involves a lack of assurance of sterility in a compounded injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 670 vials of HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial. The recall was initiated because of a lack of assurance of sterility for the sterile compounded products.
The affected products are identified by NDC 45183-0813-68 and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana. The distribution pattern indicates the products were shipped nationwide, specifically to VA and 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 facilities should check their inventory for these specific vials. Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences may occur.
The recalled product
- Product
- HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Injectable
- Affected units
- 670
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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