The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0992-2017·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 because of 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 significant injury or property damage reports or high-risk scenarios.

Plain-English summary

PharMEDium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag. The recall is being conducted due to a lack of assurance of sterility resulting from a media fill failure at the manufacturer.

The affected product is identified by NDC 61553-298-48. The specific lots subject to this recall are 171210102S (expiration date 7/31/2017), 171320109S (expiration date 8/13/2017), and 171560012S (expiration date 9/4/2017). The product was distributed nationwide.

Healthcare providers and patients should check their inventory and discontinue use of the affected lots. Consumers should contact their healthcare provider or pharmacist for guidance regarding the replacement or disposal of these specific products.

The recalled product

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 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 2K5298 NDC# 61553-298-48NDC# 61553-298-48
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 (3)

  • Lots: 171210102S Exp. 7/31/2017
  • 171320109S Exp. 8/13/2017
  • 171560012S Exp. 9/4/2017

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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