The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0987-2017·Announced 2017-07-26

PharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns

PharMedium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

PharMedium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection. The recall was initiated due to a lack of assurance of sterility resulting from a media fill failure at the manufacturer. The affected products are available in 100 mL, 150 mL, and 250 mL Intravia Bags, with specific lot numbers and expiration dates listed in the recall notice.

The distribution of these products was nationwide. The source text does not report any illnesses or injuries associated with the use of these products. The hazard is theoretical, based on the potential for contamination due to the manufacturing failure.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not used. Consumers and healthcare facilities should contact PharMedium Services for further instructions or to arrange for the return of the recalled product.

The recalled product

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC#…
Manufacturer
PharMedium Services, Llc
Category
Drug — Injectable
Hazard

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 (20)

  • Lots: a) 171320006S Exp. 8/13/2017
  • 171320014D Exp. 8/13/2017
  • 171360020D Exp. 8/15/2017
  • 171520063D Exp. 8/31/2017
  • b) 171280054D Exp. 8/7/2017
  • 171320002D Exp. 8/10/2017
  • 171370005S Exp. 8/15/2017
  • 171440016D Exp. 8/23/2017
  • 171450012D Exp. 8/24/2017
  • 171510059D Exp. 8/30/2017
  • 171560027D Exp. 9/4/2017
  • c) 171170014S Exp. 7/27/2017
  • 171210127S Exp. 7/31/2017
  • 171230071D Exp. 8/2/2017
  • 171240002D Exp. 8/3/2017
  • 171240004D Exp. 8/3/2017
  • 171240191S Exp. 8/3/2017
  • 171280041D Exp. 8/7/2017
  • 171290077D Exp. 8/8/2017
  • 171300076D Exp. 8/9/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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.

See all 13 products in this recall →

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