The Recall Desk
HighFDA (Drugs)·D-0722-2023·Announced 2023-05-31

Vancomycin Injectable Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services recalls 9,037 bags of vancomycin injectable due to FDA concerns about sterility assurance. Products distributed nationwide may not meet required sterility standards.

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: FDA Class II recall for sterile injectable products where sterility assurance has been called into question by FDA inspection. No illnesses have been reported, but the recall addresses a risk-of-harm scenario where contamination could cause serious patient injury.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 9,037 bags of vancomycin added to 0.9% sodium chloride injection (1.5 g/250 mL, NDC 71285-6076-1) distributed nationwide in the United States.

Following an FDA inspection, the agency raised questions about whether these products maintain the sterility required for injectable medications intended for intravenous use.

The recall affects healthcare facilities and providers who received affected lots, which have expiration dates ranging from May 1, 2023 through June 7, 2023. A complete list of affected lot numbers is available from the recalling firm.

Healthcare providers should identify any affected products in their inventory and discontinue use. They should contact Central Admixture Pharmacy Services, Inc. or the FDA with questions about the recall.

The recalled product

Product
vancomycin added to 0.9% sodium chloride, 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 71285-6076-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Admixture
Hazard
  • lack-of-sterility
  • contamination

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 # 37-883390
  • 37-883435
  • Exp 05/01/2023
  • 37-884157
  • Exp 05/03/2023
  • 37-885716
  • 37-886036
  • 37-886039
  • Exp 05/09/2023
  • 37-887499
  • 37-887500
  • Exp 05/16/2023
  • 37-887778
  • Exp 05/17/2023
  • 37-888105
  • Exp 05/18/2023
  • 37-889216
  • Exp 05/23/2023
  • 37-890923
  • 37-890928

Distribution

Distributed nationwide across the United States.

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