The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0986-2017·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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or other adverse health consequences.

Plain-English summary

PharMEDium Services, LLC is voluntarily recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol. The affected products are available in two configurations: 100 mL in 150 mL Intravia Bags (NDC 61553-288-48) and 250 mL in 250 mL Intravia Bags (NDC 61553-281-11). The recall is limited to specific lot numbers and expiration dates listed in the product details, including lots expiring between August 6, 2017, and August 15, 2017.

The recall was initiated due to a lack of assurance of sterility resulting from a media fill failure at the manufacturer. A media fill failure indicates that the manufacturing process did not meet the required standards to guarantee the product remained sterile. The FDA has classified this recall as Class II, which is a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should check their inventory for the specific NDCs and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received these specific lots should contact their healthcare provider for guidance.

The recalled product

Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130…
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 (6)

  • Lots: a) 171280006S Exp. 8/6/2017
  • 171280125S Exp. 8/7/2017
  • 171290006S Exp. 8/7/2017
  • 171290028D Exp. 8/8/2017
  • 171360002S Exp. 8/15/2017
  • b) 171280011S Exp. 8/7/2017

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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