Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Morphine Sulfate syringes because the company cannot guarantee the products are 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a sterile compounded product, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 30 units of Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe. The recall is being conducted because the company lacks assurance of the sterility of the affected products. The products are prescription-only and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.
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. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or healthcare provider for further instructions. The recall is voluntary and is being conducted to ensure patient safety.
The recalled product
- Product
- Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 30
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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