The Recall Desk
HighFDA (Drugs)·D-0966-2023·Announced 2023-08-09

Vancomycin IV Bags Recalled for Sterility Assurance Issues

Central Admixture Pharmacy Services is recalling 3,648 bags of vancomycin IV bags due to lack of assurance of sterility caused by insufficient validation data for decontamination cycles.

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 FDA Class II recall for potential contamination in an intravenous medication does not report illnesses or hospitalizations in the source text. Per the rubric, risk-of-harm products where injury has not been reported score at level 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 3,648 bags of vancomycin 1.5 g/250 mL in 0.9% sodium chloride IV bags due to lack of assurance of sterility. The manufacturer lacked validation data for the decontamination cycles used in preparation.

The recalled product was distributed nationwide. The affected lots and expiration dates are: 36-239524 (7/12/2023), 36-240843 (7/18/2023), 36-241437 (7/20/2023), 36-242698 (7/26/2023), 36-243152 (7/27/2023), 36-245567 (8/2/2023), 36-251063 (8/24/2023), 36-252193 (8/31/2023), and 36-255122, 36-255123, 36-255124 (9/6/2023).

The recalled product

Product
vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6076-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / IV
Hazard
Affected units
3,648

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: 36-239524
  • Exp. 7/12/2023
  • 36-240843
  • Exp. 7/18/2023
  • 36-241437
  • Exp. 7/20/2023
  • 36-242698
  • Exp. 7/26/2023
  • 36-243152
  • Exp. 7/27/2023
  • 36-245567
  • Exp. 8/2/2023
  • 36-251063
  • Exp. 8/24/2023
  • 36-252193
  • Exp. 8/31/2023
  • 36-255122
  • 36-255123
  • 36-255124
  • Exp. 9/6/2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 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 95 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · contamination risk

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