Pharmakon Recalls Cefazolin 2GM Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 5% Dextrose 50 mL due to a lack of assurance of sterility. The recall affects 1,450 units distributed nationwide.
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 infection, meeting the criteria for a Severe rating.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Cefazolin 2GM added to 5% Dextrose 50 mL USP, a prescription-only compounded sterile product. The recall was initiated because of a lack of assurance of sterility for the product.
The recall covers 1,450 units of the medication, identified by NDC 45183-0610-41. The product was distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall applies to all sterile compounded products within their expiry dates.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Affected units
- 1,450
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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