Pharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error
Pharmedium Services is recalling 48 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 indicates a low risk of adverse health consequences. The issue is a minor labeling error regarding volume, with no reported injuries or illnesses.
Plain-English summary
Pharmedium Services, LLC is recalling 48 bags of Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag (NDC# 61553-0287-48). The product is a prescription-only intravenous solution manufactured in Sugar Land, Texas.
The recall was initiated because the total volume printed on the product label is incorrect. The label states the volume is 106.67 mL, but the actual total volume is 100.00 mL. The affected lot numbers are 170100124S (dated 4/11/2017) and 170390015S (dated 5/10/2017).
The product was distributed nationwide in the USA. Healthcare providers and patients should verify the volume on the label against the actual contents of the bag. If the label indicates 106.67 mL, the product should not be used and should be returned to the distributor or manufacturer.
The recalled product
- Product
- Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 48
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 (4)
- Lot Numbers: 170100124S
- 4/11/2017
- 170390015S
- 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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