Pharmakon Recalls Magnesium Sulfate Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 72 bags of Magnesium Sulfate in Lactated Ringers 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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a sterile compounded product (implying significant injury risk from lack of sterility) maps to a score of 4 (Severe), as it exceeds the criteria for 'High' which typically applies to theoretical risks or specific pathogens without reported illness.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 72 bags of Magnesium Sulfate 50 GM in Lactated Ringers 500 mL. The recall is being conducted because of a lack of assurance of sterility for the sterile compounded products. The affected products are prescription-only and were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.
The recall covers all sterile compounded products within their expiry dates. The distribution pattern indicates the products were shipped nationwide, as well as to specific VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Consumers and healthcare providers should check their inventory for the specific NDC 45183-0407-03 and discontinue use of the affected bags. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 72
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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