The Recall Desk
HighFDA (Drugs)·D-0752-2023·Announced 2023-05-31

Potassium Acetate Injection Recalled for Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.

What this means for you

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 injectable medication where the agency's inspection raised concerns about sterility assurance. Although no illnesses or injuries have been reported, the potential harm from non-sterile injectables makes this a high-risk product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Potassium Acetate Injection, 2 mEq/mL, 500 ml bags. The recall is nationwide, affecting 3,326 bags distributed throughout the United States.

The recall was initiated following an FDA inspection that called into question the sterility of the products. Potassium Acetate Injection is an injectable medication intended to be sterile. The FDA's concerns about sterility assurance pose patient safety risks.

The affected product includes multiple lot numbers: 37-884108, 37-884109, 37-884957, 37-885047, 37-885048, 37-885919, 37-889426, 37-889432, 37-891933, 37-894274, 37-896048, 37-896049, and 37-897798, with expiration dates from May 3, 2023 to June 27, 2023.

Healthcare providers and pharmacies that received affected product should stop using it immediately. Contact the manufacturer or the FDA for further instructions.

The recalled product

Product
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
3,326

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 (20)

  • Lot # 37-884108
  • 37-884109
  • Exp 05/03/2023
  • 37-884957
  • Exp 05/07/2023
  • 37-885047
  • 37-885048
  • Exp 05/08/2023
  • 37-885919
  • Exp 05/10/2023
  • 37-889426
  • 37-889432
  • Exp 05/24/2023
  • 37-891933
  • Exp 06/05/2023
  • 37-894274
  • Exp 06/13/2023
  • 37-896048
  • 37-896049
  • Exp 06/20/2023

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 →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility concern

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