The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0723-2023·Announced 2023-05-31

Drug Recall: Vancomycin Injectable Lacks Sterility Assurance

Central Admixture Pharmacy Services recalls 7,632 bags of vancomycin injectable (NDC 71285-6078-1) nationwide due to FDA-identified sterility assurance deficiency.

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. The recall addresses lack of assurance of sterility following FDA inspection, which presents a potential risk to patients receiving this medication. The score reflects the rubric criterion for risk-of-harm products where injury has not yet been reported, appropriate for Class II recalls lacking confirmed adverse events.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 7,632 bags of vancomycin added to 0.9% sodium chloride injection (2 g/500 mL, 500 mL per bag) nationwide. The affected product carries NDC 71285-6078-1 and includes multiple lot numbers with various expiration dates between May and June 2023.

The recall was initiated because an FDA inspection called into question the sterility assurance of these products. Since vancomycin injectables are intended to be sterile, any uncertainty about sterility presents a potential risk to patients who receive this medication.

Healthcare professionals who have this product should stop using it immediately and contact the manufacturer for instructions on returning or disposing of the affected units.

The recalled product

Product
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
7,632

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 # 37-884151
  • 37-884153
  • Exp 05/03/2023
  • 37-885670
  • 37-885869
  • 37-885900
  • Exp 05/09/2023
  • 37-886271
  • Exp 05/11/2023
  • 37-886857
  • 37-886862
  • 37-886865
  • 37-886923
  • Exp 05/15/2023
  • 37-889190
  • 37-889191
  • Exp 05/23/2023
  • 37-889596
  • Exp 05/24/2023
  • 37-890482

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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