Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 200 units of compounded Ketamine 50mg/mL 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.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 200 units of Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringes. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is identified by NDC # 45183-0603-78. The recall is being conducted because of a lack of assurance of sterility.
The affected products were 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 affected syringes and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Sterile Drug
- Affected units
- 200
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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