Pharmakon Recalls Hydromorphone IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags 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 involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 675 units of Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bags. The product is compounded and intended for intravenous use only. The recall was initiated because of a lack of assurance of sterility.
The affected product is identified by NDC 45183-0865-41. The recall covers all sterile compounded products within their expiry dates. The distribution pattern is listed as nationwide, with specific mentions of VA/DOD locations in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded IV
- Affected units
- 675
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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