Pharmakon Recalls Midazolam HCI Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI 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 source text identifies the agency classification as Class II. Per the rubric, an FDA Class II recall involving a sterile product defect (lack of assurance of sterility) is classified as Severe (Score 4) due to the risk of significant injury or infection, even without explicit reports of hospitalization in the provided text.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 2,000 units of Midazolam HCI 1mg/mL in 0.9% Sodium Chloride, 2 mL fill in a 3 mL syringe. The recall was initiated due to a lack of assurance of sterility for the sterile compounded products.
The affected products are identified by NDC 45183-0966-69 and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana. The distribution pattern is listed as nationwide, with specific mentions of VA/DOD locations 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 syringes and contact their pharmacist or the recalling firm for further instructions. 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.
The recalled product
- Product
- Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 2,000
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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