Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 300 bags of Morphine Sulfate 1mg/mL due to a lack of assurance of sterility. The product was 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 300 units of Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL Intravia bags. The recall is being conducted because of a lack of assurance of sterility for the compounded product. The affected product is identified by NDC 45183-0876-41 and includes all sterile compounded products within their expiry dates.
The recalled product was distributed nationwide, as well as to specific VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 300
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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