Pharmedium Recalls Potassium Chloride Injection Bags Due to Labeling Error
Pharmedium Services is recalling 240 bags of Potassium Chloride Injection due to a labeling error where Potassium Phosphate was printed on the label stock.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmedium Services, LLC is recalling 240 bags of Potassium Chloride added to 5% Dextrose Injection, 20 mEq 250 mL Bag (NDC 61553-836-11). The recall is due to a labeling error where Potassium Phosphate was printed on the Potassium Chloride label stock, resulting in both names appearing on the label of the 250 mL bags.
The affected product is identified by Lot # 161300033M with an expiration date of 07/26/16. The distribution pattern is listed as NY. This recall is classified as Class II by the FDA.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. They should contact Pharmedium Services for further instructions on how to return or dispose of the affected bags.
The recalled product
- Product
- Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 240
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 (2)
- Lot# 161300033M
- Exp 07/26/16
Distribution
Distributed in 1 state:
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