Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 600 vials of compounded Ketamine 100mg/mL due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 600 units of Ketamine 100mg/mL 1mL fill 3 mL syringes. The recall is being conducted due to a lack of assurance of sterility in the compounded product. The affected product is identified by NDC 45183-0709-78 and is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.
The recall covers all sterile compounded products within their expiry date. Distribution was nationwide, specifically to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 600
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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