The Recall Desk
HighFDA (Drugs)·D-0716-2023·Announced 2023-05-31

IV Potassium Phosphate Solution Recalled Due to Sterility Concerns

Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The lack of sterility assurance in an injectable pharmaceutical represents a risk-of-harm to patients who receive these products, but no actual adverse health events have been documented.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 9,432 bags of potassium phosphate 15 mmole injection in 0.9% sodium chloride (250 mL per bag) distributed nationwide. The recall was initiated after an FDA inspection raised questions about whether these products maintain sterility, a critical requirement for injectable medications.

These products are prescription-only injectable solutions intended for hospital and pharmacy use. Affected lot numbers span from 37-883769 (expiration 05/02/2023) through 37-897839 (expiration 06/27/2023).

Healthcare providers should identify whether they have received any of the affected lots by checking product lot numbers. Any unused bags from the affected lots should not be dispensed and should be quarantined for return to the manufacturer.

The recalled product

Product
potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Solution
Hazard
  • lack-of-sterility
  • contamination-risk

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 # 37-883769
  • Exp 05/02/2023
  • 37-884449
  • Exp 05/04/2023
  • 37-885585
  • Exp 05/09/2023
  • 37-885922
  • Exp 05/10/2023
  • 37-886526
  • Exp 05/14/2023
  • 37-887387
  • Exp 05/16/2023
  • 37-887659
  • 37-887662
  • Exp 05/17/2023
  • 37-889064
  • Exp 05/23/2023
  • 37-889735
  • 37-889745
  • Exp 05/25/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category