Pharmakon Recalls Midazolam HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 45 bags of compounded Midazolam HCI due to a lack of assurance of sterility. The products were 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 recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 45 bags of Midazolam HCI 1mg/mL in 0.9% Sodium Chloride. The product is compounded in 150 mL Intravia bags and is marked as Rx Only. The recall is being conducted because of a lack of assurance of sterility.
The affected products were distributed nationwide as well as 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.
Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 45
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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