The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0991-2017·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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for potential serious, reversible health consequences.

Plain-English summary

PharMEDium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag. The recall was initiated because of a lack of assurance of sterility resulting from a media fill failure at the manufacturer.

The affected product is identified by NDC# 61553-284-48. The specific lots subject to the recall are 171220061D (Exp. 8/1/2017), 171250023D (Exp. 8/6/2017), 171430008D (Exp. 8/22/2017), 171450015D (Exp. 8/24/2017), and 171510062D (Exp. 8/30/2017). The product was distributed nationwide.

Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC at 800-523-7749 for further instructions or to arrange for a return or replacement.

The recalled product

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
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 (5)

  • Lots: 171220061D Exp. 8/1/2017
  • 171250023D Exp. 8/6/2017
  • 171430008D Exp. 8/22/2017
  • 171450015D Exp. 8/24/2017
  • 171510062D Exp. 8/30/2017

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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