Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,809 units of compounded Oxytocin infusion bags nationwide due to a lack of assurance of sterility.
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 medical product, which poses a significant risk of serious injury or infection.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 1,809 units of Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL Intravia bag. The product is identified by NDC 45183-0740-04 and was compounded by Pharmakon in Noblesville, Indiana. The recall is being conducted because of a lack of assurance of sterility.
The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.
Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals for further instructions or replacement.
The recalled product
- Product
- Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0740-04
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Affected units
- 1,809
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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