Agency classClass IIOur severity:Severe FDA (Drugs)·D-1033-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Potassium Chloride Injection Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL due to lack of assurance of sterility and potential for leaking.

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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an IV product is a significant safety risk that aligns with the upper end of Class II severity.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling specific lots of Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, a prescription-only intravenous solution. The recall is being conducted because the product lacks assurance of sterility and has the potential to leak.

The affected product is identified by NDC# 70004-0833-40. The specific lot number is 20170509@10, with a beyond-use date of July 23, 2017. The recall is distributed nationwide.

Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals or their local FDA office 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: Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
Manufacturer: SCA Pharmaceuticals
Category: Drug — Intravenous Solution
Hazard: sterility
leakage

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)

Lots: 20170509@10 BUD: 7/23/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by SCA Pharmaceuticals 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 30 products in this recall →

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