Agency classClass IIOur severity:Severe FDA (Drugs)·D-1280-2016·Announced 2016-07-20

Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling 18 units of Cefazolin 3GM in 0.9% Sodium Chloride bags 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 FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile medical product where sterility is not assured is classified as Severe (Score 4) due to the risk of infection.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling 18 units of Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag. The product is prescription-only and was compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by NDC 45183-0223-48. The recall covers all sterile compounded products within their expiry date. The distribution pattern indicates the product was distributed nationwide, with specific mentions of VA/DOD locations in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia.

Consumers and healthcare providers should stop using the affected product and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions. The FDA has classified 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: Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48
Manufacturer: Pharmakon Pharmaceuticals, Inc.
Category: Drug — Sterile Compounded Product
Hazard: lack-of-sterility
Affected units: 18

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 · lack of sterility