The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0990-2017·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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential sterility failures in injectable medications which carry significant risk.

Plain-English summary

PharMEDium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL. The recall is being conducted because of a lack of assurance of sterility resulting from a media fill failure at the manufacturer.

The affected product is an intravenous injection intended for prescription use only. The recall covers four specific lots: 171220007S (Exp. 7/31/2017), 171280129S (Exp. 8/7/2017), 171320112S (Exp. 8/13/2017), and 171590010S (Exp. 9/7/2017). The product was distributed nationwide.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If the product is found, it should be quarantined and not administered. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
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 (4)

  • Lots: 171220007S Exp. 7/31/2017
  • 171280129S Exp. 8/7/2017
  • 171320112S Exp. 8/13/2017
  • 171590010S Exp. 9/7/2017

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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