The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0721-2023·Announced 2023-05-31

Vancomycin and Dextrose Injection Sterility Recall by Central Admixture

Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.

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 involving sterility assurance for an injectable pharmaceutical product intended for intravenous use. No illnesses, injuries, or deaths have been reported. The hazard represents a potential loss of sterility assurance rather than confirmed contamination, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 10,282 bags of vancomycin added to dextrose 5% (1.5 g/250 mL, 6 mg/mL). The affected product is supplied as 250 mL bags per unit with NDC 71285-6075-1.

The recall was initiated after an FDA inspection raised concerns about whether these injectable products maintain sterility assurance. The manufacturer has determined it cannot provide adequate assurance of sterility for the affected batches.

The product was distributed nationwide in the USA. Affected lot numbers include 37-883196, 37-883197, 37-883205, 37-884882, 37-884890, 37-884898, 37-886840, 37-886858, 37-886863, 37-887365, 37-887663, 37-888254, 37-888257, 37-888265, 37-888303, 37-889453, 37-890037, 37-890039, 37-890043, 37-890330, 37-890333, 37-890344, 37-892009, 37-892011, 37-892016, 37-892881, 37-893448, and 37-895221, with expiration dates ranging from April 30, 2023 through June 29, 2023.

Individuals and facilities in possession of the affected lots should immediately stop using them and refer to recall instructions from the manufacturer or contact the FDA for guidance on proper disposal and handling.

The recalled product

Product
vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Pharmaceutical
Hazard
Affected units
10,282

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 # 37-883196
  • 37-883197
  • 37-883205
  • Exp 04/30/2023
  • 37-884882
  • 37-884890
  • 37-884898
  • Exp 05/07/2023
  • 37-886840
  • 37-886858
  • 37-886863
  • Exp 05/15/2023
  • 37-887365
  • Exp 05/16/2023
  • 37-887663
  • Exp 05/17/2023
  • 37-888254
  • 37-888257
  • 37-888265
  • 37-888303

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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