The Recall Desk
HighFDA (Drugs)·D-0751-2023·Announced 2023-05-31

Injection Solution Recalled Due to Sterility Assurance Concerns

Nationwide recall of Sodium Phosphates Injection due to lack of sterility assurance after FDA inspection. Patients receiving this medication should consult their healthcare provider.

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 of injectable medication due to sterility assurance concerns. No reported illnesses or injuries, but sterile injectables are inherent risk-of-harm products where contamination could cause serious infection.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Sodium Phosphates Injection, 4 mEq/3 mMol/mL, 500 ml bags, nationwide. Approximately 3,165 bags were distributed across the United States.

The FDA inspection raised questions about whether the company could assure the sterility of these products. Sodium Phosphates Injection is an intravenous medication that must be sterile to be safe for use. Non-sterile injectables pose a risk of serious infection to patients who receive them.

Affected lot numbers include 37-883239, 37-883240, 37-884419, 37-884423, 37-889009, 37-890261, 37-890262, 37-891250, 37-891412, 37-895488, 37-896456, and 37-898159, with expiration dates ranging from May 1, 2023 through June 28, 2023.

Patients who have received this medication should consult their healthcare provider immediately. Healthcare providers should discontinue use of affected lots and contact Central Admixture Pharmacy Services or the FDA for additional information.

The recalled product

Product
Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Intravenous Solution
Hazard
Affected units
3,165

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 # 37-883239
  • 37-883240
  • Exp 05/01/2023
  • 37-884419
  • 37-884423
  • Exp 05/04/2023
  • 37-889009
  • Exp 05/23/2023
  • 37-890261
  • 37-890262
  • Exp 05/29/2023
  • 37-891250
  • Exp 05/31/2023
  • 37-891412
  • Exp 06/01/2023
  • 37-895488
  • Exp 06/19/2023
  • 37-896456
  • Exp 06/21/2023
  • 37-898159

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 failure

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