The Recall Desk
HighFDA (Drugs)·D-1136-2023·Announced 2023-09-06

Vancomycin Injectable Recalled for Lack of Sterility Validation

Central Admixture Pharmacy Services is recalling vancomycin injections nationwide (477 bags, lots 36-262215 and 36-262216) due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.

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 involving a sterile injectable medication with lack of validated sanitization processes. While no illnesses or injuries have been reported, the potential for microbial contamination in an intravenous drug represents a high-risk hazard to patient safety.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling vancomycin added to 0.9% Sodium Chloride injection nationwide. The recalled product is supplied in 250 mL Excel Bags at a concentration of 1.25 g/250 mL (5 mg/mL). The recall affects 477 bags from lots 36-262215 and 36-262216, which expire October 5, 2023.

The manufacturer initiated the recall because it lacks validation data for the sanitization cycles used to prepare this sterile injectable product. Without documented evidence that sanitization processes adequately eliminate microbial contamination, the sterility of the medication cannot be assured. Sterility is critical for intravenous drugs, as any contamination could cause serious infection.

Healthcare providers should immediately quarantine remaining product from the affected lots and identify alternative sources of vancomycin. Patients who have received doses from these specific lots should contact their healthcare provider. Patients should not discontinue vancomycin without medical guidance, as abrupt cessation could compromise their treatment.

For questions about this recall, contact Central Admixture Pharmacy Services, Inc., located at 2200 South 43rd Avenue, Phoenix, AZ 85043.

The recalled product

Product
vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
  • lack-of-sterility
  • contamination-risk
  • sanitization-validation-failure

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 (3)

  • Lot# 36-262215
  • 36-262216
  • Exp 10/5/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category