The Recall Desk
SevereFDA (Drugs)·D-0996-2017·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 at the manufacturer that raises concerns about sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

PharMEDium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol, in 250 mL and 500 mL Intravia Bags. 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 prescription-only (Rx Only) and include specific lot numbers with expiration dates ranging from July 29, 2017, to September 4, 2017. The distribution pattern is listed as nationwide.

Healthcare providers and patients should stop using the affected lots and contact PharMEDium Services or their healthcare provider for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Lan
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 (16)

  • Lots: a) 171180027S Exp. 7/29/2017
  • 171220058D Exp. 8/1/2017
  • 171230013S Exp. 8/2/2017
  • 171360008S Exp. 8/14/2017
  • 171360019D Exp. 8/15/2017
  • 171380085D Exp. 8/17/2017
  • 171430069D Exp. 8/22/2017
  • 171560025D Exp. 9/4/2017
  • b) 171240007S Exp. 8/3/2017
  • 171280055D Exp. 8/7/2017
  • 171320003D Exp. 8/10/2017
  • 171320008S Exp. 8/13/2017
  • 171360005S Exp. 8/14/2017
  • 171370011S Exp. 8/16/2017
  • 171380086D Exp. 8/17/2017
  • 171500071D Exp. 8/29/2017

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 →

Related recalls

Same manufacturer · PharMedium Services, Llc

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Same hazard · sterility failure

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