Agency classClass IIOur severity:Severe FDA (Drugs)·D-1330-2016·Announced 2016-07-20

Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 800 units of Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringes. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is identified by NDC 45183-0939-70.

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 recalled products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Injectable Sterile Compounded
Hazard: sterility-failure
Affected units: 800

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 failure