The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1311-2016·Announced 2016-07-20

Pharmakon Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling Norepinephrine Bitartrate 4 mg in 5% Dextrose bags 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 parenteral product, which poses a risk of serious adverse health consequences such as infection or sepsis, meeting the criteria for a Severe rating.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bags. The recall is being conducted because the company lacks assurance of the sterility of these compounded sterile products. The affected products are prescription-only and 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. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected Norepinephrine Bitartrate bags and contact Pharmakon Pharmaceuticals for further instructions or to arrange for a return or replacement.

The recalled product

Product
Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Sterile Compounded Product
Hazard
Affected units
250

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 →

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