The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0728-2023·Announced 2023-05-31

Potassium Phosphate Drug Product Recalled for Sterility Assurance Defect

Central Admixture Pharmacy Services recalled 2,146 bags of potassium phosphate with sodium chloride solution nationwide because FDA inspection raised concerns about whether the sterile products met required sterility standards.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile drug product where the manufacturer's sterility assurance was questioned by FDA inspection. No illnesses or injuries have been reported. The hazard is theoretical but applies to a high-risk product category where contamination could result in serious harm.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,146 bags of potassium phosphate 30 mmole in 0.9% sodium chloride, 500 mL per bag (NDC 71285-7016-1), distributed nationwide. The recall was initiated after an FDA inspection questioned whether these sterile products met required sterility standards.

The affected lots include: 37-883219 (Exp 04/30/2023), 37-885926 (Exp 05/10/2023), 37-887382 (Exp 05/16/2023), 37-889455 (Exp 05/24/2023), 37-890060 (Exp 05/28/2023), 37-893444 (Exp 06/11/2023), and 37-894987 (Exp 06/15/2023).

These prescription-only products were distributed nationwide. Healthcare providers and patients who have received or have in their possession any of the recalled lots should contact Central Admixture Pharmacy Services or the FDA for instructions.

The recalled product

Product
potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug
Hazard
Affected units
2,146

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 (14)

  • Lot # 37-883219
  • Exp 04/30/2023
  • 37-885926
  • Exp 05/10/2023
  • 37-887382
  • Exp 05/16/2023
  • 37-889455
  • Exp 05/24/2023
  • 37-890060
  • Exp 05/28/2023
  • 37-893444
  • Exp 06/11/2023
  • 37-894987
  • Exp 06/15/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. 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 108 products in this recall →

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Same manufacturer · Central Admixture Pharmacy Services, Inc.

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