SCA Pharmaceuticals Recalls Potassium Chloride Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Potassium Chloride 20 meq in Sodium Chloride 0.9% injection due to a 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
SCA Pharmaceuticals is recalling specific lots of Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, a prescription-only intravenous solution. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected product is identified by NDC number 70004-0832-40. The specific lot number is 20170501@66, with a beyond-use date of July 15, 2017. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should discontinue use of the affected lots and contact SCA Pharmaceuticals for further instructions. The product was distributed nationwide.
The recalled product
- Product
- Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40
- 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: 20170501@66 BUD: 7/15/2017
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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