Agency classClass IIOur severity:High FDA (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.

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: 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
Affected units: 10,065

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.

Part of a larger recall action

This product is one of 39 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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Same hazard · sterility failure