FDA Recalls Rocuronium Syringes Due to Sterility Assurance Issue
The FDA is recalling rocuronium 50 mg/5 mL syringes from Central Admixture Pharmacy Services Inc due to lack of assurance of sterility. Approximately 1,389 syringes with affected lot numbers have been 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 of an injectable drug lacking sterility assurance. No illnesses or injuries reported. Classified as High because injectable medications require sterility, and this represents a risk-of-harm product without confirmed injury.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling rocuronium 50 mg/5 mL (10 mg/mL) syringes due to lack of assurance of sterility. This drug is used during anesthesia and critical care procedures. Approximately 1,389 syringes with the affected lot numbers have been distributed nationwide.
The recalled lots are 17-275634 (expiration date 10/8/2023), 17-275860 (expiration date 10/11/2023), and 17-276174 (expiration date 10/18/2023). The product is identified by NDC 71286-6010-1 and manufactured at 7935 Dunbrook Road, Suite C, San Diego, California 92126.
Healthcare providers and facilities with these products should discontinue use of affected lots and contact the recalling manufacturer or their supplier regarding return or replacement 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
- Hazard
- sterility-defect
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 (6)
- Lot: 17-275634
- Exp. 10/8/2023
- 17-275860
- Exp. 10/11/2023
- 17-276174
- Exp. 10/18/2023
Distribution
Distributed nationwide across the United States.
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