Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml 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 severity score under the rubric for significant injury or property damage reports, or high-risk contamination.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 800 units of Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringes. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is identified by NDC 45183-0939-70.
The recall was initiated because of a lack of assurance of sterility. The affected products are all sterile compounded products within their expiry dates.
The recalled products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 800
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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