The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0725-2023·Announced 2023-05-31

Vancomycin Sodium Chloride Injection Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 11,338 bags of vancomycin sodium chloride injection nationwide due to FDA concerns about product sterility following an inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 of a sterile injectable product due to questioned sterility assurance following an FDA inspection. No illnesses, injuries, or confirmed contamination have been reported. The score is High (3) because the hazard involves a critical product attribute (sterility) without confirmed harm.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling vancomycin added to 0.9% sodium chloride injection (1.5 g/500 mL, 3 mg/mL) distributed nationwide. The recall affects 11,338 bags of this prescription medication across multiple lot numbers with expiration dates ranging from May 2023 through June 2023.

The recall was initiated after an FDA inspection called into question the sterility assurance of the product. Vancomycin is a sterile injectable antibiotic medication, and any compromise to sterility could pose a serious health risk to patients receiving the medication.

Healthcare facilities that received affected lots should cease use immediately and contact Central Admixture Pharmacy Services or the FDA with any questions. Specific lot numbers and expiration dates have been identified by the manufacturer. Patients should not stop taking prescribed vancomycin therapy but should consult with their healthcare provider or pharmacist about whether their medication may be affected by this recall.

The recalled product

Product
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Pharmacy Admixture
Hazard
Affected units
11,338

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 # 37-883372
  • 37-883387
  • Exp 05/01/2023
  • 37-883790
  • Exp 05/02/2023
  • 37-884160
  • Exp 05/03/2023
  • 37-885320
  • 37-885321
  • 37-885324
  • Exp 05/08/2023
  • 37-885921
  • 37-885928
  • 37-885930
  • Exp 05/10/2023
  • 37-886270
  • Exp 05/11/2023
  • 37-887511
  • Exp 05/16/2023
  • 37-887666

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 →

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Same manufacturer · Central Admixture Pharmacy Services, Inc.

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