Pharmakon Recalls Midazolam Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 40 vials of compounded Midazolam (PF) 5mg/ml 25 mL BD syringes 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 a compounded 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 40 units of Midazolam (PF) 5mg/ml 25 mL BD syringes. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries NDC # 45183-0138-67. The recall is classified as Class II by the FDA.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or report any specific illnesses or injuries associated with the product.
The affected units were 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 affected product and contact Pharmakon Pharmaceuticals for further instructions.
The recalled product
- Product
- Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 40
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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