Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding volume.
Plain-English summary
Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride added to 0.9% Sodium Chloride, 30mEq 100 mL Bag. The product is identified by NDC# 61553-0824-48 and Service Code 2K5824. The recall is due to a labeling error where the total volume is incorrectly printed as 115.00 mL on the product label, whereas the actual total volume is 100.00 mL.
The affected lots are 70090135M, 170250101M, 170030011D, 170040078D, 170310012D, and 170400046D. These products were distributed nationwide in the USA. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected bags. The product is prescription-only (Rx Only). No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 216
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 (12)
- Lot Numbers: 70090135M
- 2/27/2017
- 170250101M
- 3/15/2017
- 170030011D
- 4/4/2017
- 170040078D
- 4/5/2017
- 170310012D
- 5/2/2017
- 170400046D
- 5/11/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Pharmedium Services, LLC 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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