FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam in 5% dextrose solution (50 mg per 50 mL, 1 mg per mL, supplied in 50 mL syringes). The product was distributed nationwide in the United States.

The recall was initiated because the manufacturer lacked validation data for its sanitization cycles. Without this validation, there is no documented assurance that the sterilization process was effective, creating uncertainty about the sterility of the recalled syringes.

Customers who received this product should identify units by lot number and expiration date. The recalled lots are: 17-270666 (expires 7/18/2023), 17-270879 (expires 7/20/2023), 17-271669 (expires 8/2/2023), 17-272287 (expires 8/14/2023), 17-272366 (expires 8/15/2023), 17-272991 (expires 8/24/2023), and 17-273512 (expires 9/4/2023). For guidance on handling this product, contact Central Admixture Pharmacy Services Inc or the FDA.

The recalled product

Product

midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1

Manufacturer

Central Admixture Pharmacy Services Inc

Category

Drug — Injectable Medication

Hazard

• sterility-assurance
• sterilization-process

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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