Agency classClass IIOur severity:Severe FDA (Drugs)·D-1272-2016·Announced 2016-07-20

Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 24 bags of compounded Norepinephrine 16 mg 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 the hazard involves a lack of assurance of sterility in a compounded injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 24 bags of Norepinephrine 16 mg added to 0.9% sodium chloride, 250 mL bag, Rx Only. The product was compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC # 45183-0174-02.

The recall was initiated because of a lack of assurance of sterility. The affected products are all sterile compounded products within their expiry dates. The distribution pattern indicates the product was distributed nationwide, with specific mentions of VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Healthcare providers and facilities should check their inventory for this specific NDC number and stop using the product. Patients who have received this medication should contact their healthcare provider for guidance.

The recalled product

Product: Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 24

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