Agency classClass IIOur severity:Severe FDA (Drugs)·D-1308-2016·Announced 2016-07-20

Pharmakon Recalls Fentanyl and Bupivacaine Compounded Syringes for Sterility Concerns

Pharmakon Pharmaceuticals is recalling 260 syringes of compounded fentanyl and bupivacaine 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 260 units of Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and is identified by NDC # 45183-0826-77.

The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or provide details on specific lot numbers beyond the general description of all sterile compounded products within expiry.

The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Healthcare providers and patients who have received this product should contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 260

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