Pharmakon Recalls Morphine Sulfate Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes due to a lack of assurance of sterility.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries NDC 45183-0502-41.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or provide details on specific lot numbers beyond the general code information "All Sterile Compounded Products within Expiry."
The affected products were distributed nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41
- 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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