Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 72 units of compounded Oxytocin 10 Units in Lactated Ringers 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 compounded drug, 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 72 units of Oxytocin 10 Units added to Lactated Ringers in a 500 mL Intravia bag. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is available by prescription only. The recall is being conducted because of a lack of assurance of sterility.
The affected product has the NDC 45183-0764-03. The recall covers all sterile compounded products within their expiry dates. The distribution pattern is nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.
Consumers and healthcare providers should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded Drug
- Affected units
- 72
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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