The Recall Desk
HighFDA (Drugs)·D-1076-2023·Announced 2023-08-09

Rocuronium Syringes Recalled for Lack of Sterility Validation

Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.

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 without reported illnesses or injuries. The hazard—inability to assure sterility due to lack of sanitization cycle validation—represents a significant risk for an injectable medication, meeting the criterion for high severity where injury has not yet been reported but the hazard is serious.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling rocuronium 50 mg/5 mL syringes because the company lacks validation data for its sanitization cycles, which means sterility of the product cannot be assured. The FDA classified this as a Class II recall.

The affected product consists of 10,065 syringes distributed nationwide. Multiple lot numbers are affected with expiration dates ranging from July 2023 through September 2023. Rocuronium is a prescription injectable medication.

Healthcare providers in possession of affected lots should verify their lot numbers and expiration dates against the recall list to identify if they received product subject to this recall. Those who believe they have received affected product should contact Central Admixture Pharmacy Services Inc. for further instructions regarding return or destruction of the product.

The recalled product

Product
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable / Anesthetic Agent
Hazard
  • sterility-failure
  • validation-failure

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: 17-270519
  • Exp. 7/16/2023
  • 17-270605
  • Exp. 7/17/2023
  • 17-270684
  • Exp. 7/18/2023
  • 17-270898
  • Exp. 7/20/2023
  • 17-271074
  • Exp. 7/24/2023
  • 17-271324
  • Exp. 7/27/2023
  • 17-271603
  • Exp. 8/1/2023
  • 17-271670
  • Exp. 8/2/2023
  • 17-272529
  • Exp. 8/17/2023
  • 17-272883
  • Exp. 8/23/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category