Agency classClass IIOur severity:High FDA (Drugs)·D-1048-2023·Announced 2023-08-09

Vecuronium Injection Recalled Due to Lack of Sterility Validation

Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.

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 of an injectable medication with unassured sterility due to missing sanitization validation data. While vecuronium is a high-risk critical-care medication, the actual hazard is theoretical rather than confirmed contamination, placing this at the High level per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services has recalled 2,640 syringes of vecuronium injection (10 mg/10mL) distributed nationwide. The recall was initiated due to lack of validation data for sanitization cycles, which prevents assurance of product sterility.

Vecuronium is a paralyzing agent used in anesthesia and critical care. The affected product was distributed nationwide throughout the United States with multiple lot numbers, all expiring in 2023.

Patients or healthcare providers who have this product should contact their healthcare facility or pharmacy regarding the recall.

The recalled product

Product: vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable
Hazard: sterility
lack-of-validation
Affected units: 2,640

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: 17-273867
Exp.9/10/2023
17-272606
Exp.8/20/2023
17-272225
8/13/2023
17-272036
Exp. 8/9/2023
17-271503
Exp. 7/31/2023
17-271427
Exp. 7/30/2023
17-271264
Exp. 7/26/2023
17-270970
Exp.7/23/2023
17-270784
Exp. 7/19/2023
17-270674
Exp. 7/18/2023.

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