The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1258-2016·Announced 2016-07-20

Pharmakon Recalls Fentanyl and Ropivacaine Injection Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 150 bags of compounded Fentanyl Citrate and Ropivacaine HCI injection 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 and involves a lack of assurance of sterility in an injectable medication, which poses a risk of serious infection or adverse health consequences.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 150 bags of Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0029-01. The recall is being conducted because of a lack of assurance of sterility.

The affected product was 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.

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

The recalled product

Product
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — Compounded Injectable
Hazard
Affected units
150

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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