Agency classClass IIOur severity:Severe FDA (Drugs)·D-1295-2016·Announced 2016-07-20

Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin 30 Units in 0.9% Sodium Chloride 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 significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 384 units of Oxytocin 30 Units added to 0.9% Sodium Chloride 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 due to a lack of assurance of sterility.

The affected product is identified by NDC 45183-0735-03. The recall covers all sterile compounded products within their expiry dates. The distribution pattern indicates the product was distributed nationwide, with specific mentions of 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 their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Compounded Sterile Preparation
Hazard: sterility
infection
Affected units: 384

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

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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 →

Same manufacturer · Pharmakon Pharmaceuticals, Inc.

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Same hazard · sterility