Pharmakon Recalls Phenylephrine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI syringes because the company cannot ensure 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a sterile compounded product, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling Phenylephrine HCI 100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe. The recall is being conducted because the company lacks assurance of the sterility of the products.
The affected product is a prescription-only compounded medication. The recall covers 2,735 units. Distribution was nationwide, with specific mentions of distribution to VA/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 product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 2,735
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.
See all 88 products in this recall →Related recalls
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