The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0717-2023·Announced 2023-05-31

Vancomycin injection recalled due to sterility assurance concerns

Central Admixture Pharmacy Services is recalling vancomycin injections (1 g/250 mL) nationwide due to concerns about sterility assurance identified during FDA inspection. The recall affects 4,390 bags.

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 a FDA Class II recall with no reported hospitalizations, illnesses, or injuries. The hazard—lack of sterility assurance for an injectable medication—poses a theoretical risk of harm, placing it in the High severity category per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling vancomycin injections (1 g/250 mL, 4 mg/mL) distributed nationwide. The recall affects 4,390 bags across multiple lot numbers.

The FDA inspection questioned the sterility assurance of these products. Vancomycin is a prescription injectable medication that must be sterile to be safe for use.

The affected lots were distributed nationwide. Consumers and healthcare providers who have received products with the following lot numbers should stop using them: Lot #37-885351 (Exp 05/08/2023), 37-885979 (Exp 05/10/2023), 37-887721 (Exp 05/17/2023), 37-889212 (Exp 05/23/2023), 37-889607 (Exp 05/24/2023), 37-891247 (Exp 05/31/2023), 37-892937 (Exp 06/07/2023), 37-894025 (Exp 06/12/2023), 37-894748 (Exp 06/14/2023), 37-895282 (Exp 06/18/2023), 37-896173 (Exp 06/20/2023).

If you or your healthcare provider have used this medication, speak with a healthcare provider. Do not use any remaining product with the recalled lot numbers. Contact Central Admixture Pharmacy Services or the FDA with questions.

The recalled product

Product
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Antibiotic
Hazard
Affected units
4,390

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 # 37-885351
  • Exp 05/08/2023
  • 37-885979
  • Exp 05/10/2023
  • 37-887721
  • Exp 05/17/2023
  • 37-889212
  • Exp 05/23/2023
  • 37-889607
  • Exp 05/24/2023
  • 37-891247
  • Exp 05/31/2023
  • 37-892937
  • Exp 06/07/2023
  • 37-894025
  • Exp 06/12/2023
  • 37-894748
  • Exp 06/14/2023
  • 37-895282
  • Exp 06/18/2023

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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