The Recall Desk
HighFDA (Drugs)·D-0719-2023·Announced 2023-05-31

Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns

Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.

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 or injuries. The hazard is theoretical—an FDA inspection questioned sterility assurance—but actual contamination or patient harm has not been documented. This meets the High criterion for risk-of-harm products without reported injury.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling vancomycin added to dextrose 5% (1.25 g/250 mL per 250 mL bag) distributed nationwide. The recall affects 13,772 bags across multiple lot numbers, with expiration dates ranging from April 30 to June 7, 2023.

The FDA inspection called into question whether these products maintain their sterile status. Because vancomycin-dextrose is administered intravenously and is required to be sterile, any loss of sterility assurance poses a risk of infection to patients who receive the product.

Healthcare providers and pharmacies should not use any product with the affected lot numbers. Patients who received this medication should contact their healthcare provider to discuss their exposure. No illnesses or injuries have been reported to date.

The recalled product

Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Compounded Sterile Injectable
Hazard
  • sterility-assurance
  • contamination-risk
  • infection-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 # 37-883198
  • 37-883202
  • 37-883203
  • 37-883204
  • Exp 04/30/2023
  • 37-883799
  • Exp 05/02/2023
  • 37-884159
  • Exp 05/03/2023
  • 37-884888
  • 37-884892
  • 37-884899
  • 37-884901
  • Exp 05/07/2023
  • 37-886836
  • 37-886855
  • 37-886861
  • Exp 05/15/2023
  • 37-887381
  • Exp 05/16/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category