Pharmedium Recalls Potassium Chloride Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 143 bags of Potassium Chloride in 0.9% Sodium Chloride because the product label incorrectly states the total volume as 105.00 mL instead of 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 recall is classified as FDA Class III, 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 voluntarily recalling 143 bags of Potassium Chloride added to 0.9% Sodium Chloride, 10mEq 100 mL Bag. The recall is due to a labeling error where the total volume is incorrectly printed as 105.00 mL on the product label, while the actual total volume is 100.00 mL. The affected product is identified by NDC# 61553-0856-48 and Service Code 2K5856.
The affected lots were distributed nationwide in the USA. The specific lot numbers and dates are: 163640167M (3/21/2017), 170050171M (3/28/2017), 170070172M (3/31/2017), 170190235M (4/11/2017), 170200120M (4/14/2017), 170230115M (4/15/2017), and 170390059D (5/10/2017).
This recall is classified as FDA Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Healthcare providers and patients should verify the volume on the label against the actual product volume and contact the manufacturer or their pharmacy for replacement or further instructions if they have the affected lots.
The recalled product
- Product
- Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 143
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 (14)
- Lot Numbers: 163640167M
- 3/21/2017
- 170050171M
- 3/28/2017
- 170070172M
- 3/31/2017
- 170190235M
- 4/11/2017
- 170200120M
- 4/14/2017
- 170230115M
- 4/15/2017
- 170390059D
- 5/10/2017
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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