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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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.
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