Pharmakon Recalls Ceftriaxone Injections Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,575 units of compounded Ceftriaxone 1GM injections due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectable drugs) are rated as Severe (4).
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 1,575 units of Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0106-72. The recall is being conducted because of a lack of assurance of sterility.
The affected products were distributed nationwide and to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.
Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 1,575
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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