Agency classClass IIOur severity:Severe FDA (Drugs)·D-1337-2016·Announced 2016-07-20

Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL 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 sterile compounded drug where lack of sterility assurance poses a risk of serious infection, meeting the criteria for a Severe rating.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL, 5ml, Rx Only. The recall was initiated because the company lacks assurance of the sterility of the compounded products. The affected products are identified by NDC 45183-0964-70 and include all sterile compounded products within their expiry dates.

The recalled products were distributed nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the recalled fentanyl syringes and contact Pharmakon Pharmaceuticals or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product: Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 1,500

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