Pharmakon Recalls Ondansetron Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,300 units of compounded Ondansetron 2mg/mL syringes 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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury or structural defects (or in this case, a critical sterility failure in a sterile compounded product) are classified as Severe (Score 4).
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 2,300 units of Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe. The product is compounded and marked as prescription-only. The recall is being conducted because the company lacks assurance of the sterility of the product.
The affected product has the NDC 45183-0957-69 and is distributed nationwide, including to VA and 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 their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 2,300
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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