FDA Recalls Midazolam Injectable for Unvalidated Sterilization Process
Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.
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: This is an injectable medication with unvalidated sterilization processes and no documented assurance of sterility, representing a risk-of-harm product. No illnesses or injuries have been reported, placing it at severity level 3 per the rubric for risk-of-harm products where injury has not yet been reported.
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
- Affected units
- 621
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 (14)
- Lot: 17-270666
- Exp. 7/18/2023
- 17-270879
- Exp. 7/20/2023
- 17-271669
- Exp. 8/2/2023
- 17-272287
- Exp. 8/14/2023
- 17-272366
- Exp. 8/15/2023
- 17-272991
- Exp. 8/24/2023
- 17-273512
- Exp. 9/4/2023.
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.
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