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.
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 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
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.
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