Pharmakon Recalls Vecuronium Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
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 with potential for adverse health consequences (such as infection from non-sterile injectables) maps to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High due to the nature of the hazard.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 275 units of Vecuronium 1mg/mL in Sterile Water, 10 mL BD syringe, Rx Only. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0972-72. The recall is being conducted due to a lack of assurance of sterility.
The affected products were distributed nationwide as well as 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 recalled product and contact their pharmacist or the recalling firm for instructions on return or replacement. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 275
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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