The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1271-2016·Announced 2016-07-20

Pharmakon Recalls Potassium Chloride IV Bags Due to Sterility Concerns

Pharmakon Pharmaceuticals is recalling Potassium Chloride IV bags because they may not be sterile. The recall covers products 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 and involves a lack of assurance of sterility in an IV product, which poses a risk of serious injury or death if contaminated, meeting the criteria for a Severe rating.

Plain-English summary

Pharmakon Pharmaceuticals, Inc. is recalling Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bags (NDC 45183-0173-02). The recall was initiated due to a lack of assurance of sterility for the sterile compounded products.

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

Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals or their local FDA office for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02
Manufacturer
Pharmakon Pharmaceuticals, Inc.
Category
Drug — IV Infusion
Hazard
Affected units
40

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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