Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide to VA and 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 and involves a lack of assurance of sterility in a potent opioid injection, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride. The recall is being conducted because the company lacks assurance of the sterility of the compounded products. The affected product is identified by NDC 45183-0521-67 and is compounded in Noblesville, Indiana.
The recall covers all sterile compounded products within their expiry dates. The distribution pattern indicates that the products were shipped nationwide to specific VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. 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
- Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 20
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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