The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1259-2016·Announced 2016-07-20

Pharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 50 mcg/ml injections due to a lack of assurance of sterility. The recall affects 4,050 syringes distributed nationwide and to specific VA/DOD facilities.

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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the agency classification and the nature of the hazard (sterility in a sterile injection) align with the Severe criteria for Class II recalls where risk is significant.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is voluntarily recalling 4,050 syringes of Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0100-69. The recall is being conducted due to a lack of assurance of sterility.

The affected product was distributed nationwide and to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.

Consumers and healthcare providers should stop using the recalled product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. This recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Injectable
Hazard
Affected units
4,050

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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