Pharmedium Recalls IV Bags with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Phosphate in 0.9% Sodium Chloride because the total volume was incorrectly printed on the label.
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 by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding volume, with no reported injuries.
Plain-English summary
Pharmedium Services, LLC is recalling 216 bags of Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag. The product, identified by NDC# 61553-0284-48 and Service Code 2K5284, was distributed nationwide in the USA. The recall is due to a labeling error where the total volume of 100.00 mL was incorrectly printed as 102.33 mL on the product label.
The affected lot numbers are 163640084D (3/30/2017), 170120081D (4/13/2017), 170160062D (4/17/2017), 170200066D (4/23/2017), and 170370011D (5/8/2017). This is a prescription-only product. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for these specific lot numbers and stop using the affected bags. The source text does not specify further consumer actions or report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 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
- 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 (10)
- Lot Numbers: 163640084D
- 3/30/2017
- 170120081D
- 4/13/2017
- 170160062D
- 4/17/2017
- 170200066D
- 4/23/2017
- 170370011D
- 5/8/2017
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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