Pharmakon Recalls Methohexital Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL because the company cannot ensure the product is sterile.
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. According to the rubric, an FDA Class II recall involving a significant hazard (lack of sterility in a sterile compounded drug) corresponds to a 'Severe' rating (Score 4), particularly given the potential for serious injury from non-sterile administration.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL, 10 mL, Rx Only. The product was compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0180-72.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify a particular contamination event or pathogen, but indicates that the company cannot guarantee the sterile status of the compounded product.
The affected product was distributed nationwide, with specific distribution 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 product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Sterile Compounded Drug
- Hazard
- Affected units
- 225
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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