Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 100 mL 0.9% Sodium Chloride bags because the company cannot guarantee the products are sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the lack of sterility assurance in a drug) map to a score of 4 (Severe).
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bags. The recall was initiated because the company lacks assurance of the sterility of the affected products. The recall covers 1,083 units of the compounded medication, identified by NDC 45183-0216-48.
The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall includes all sterile compounded products within their expiry dates.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or healthcare provider for further instructions. The FDA classifies 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
- Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 1,083
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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