The Recall Desk
HighFDA (Drugs)·D-0018-2024·Announced 2023-10-11

Midazolam Injectable Solution Recalled Over Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.

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 a risk-of-harm product (injectable medication with unassured sterility) where no injury has been reported, fitting the High severity criterion. FDA Class II classification supports this rating in the absence of confirmed hospitalizations.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling specific lots of midazolam injectable solution (50 mg/50 mL concentration in 50 mL syringes) due to lack of assurance of sterility. The affected lots are Lot 17-275475 (expiration 10/4/2023) and Lot 17-276117 (expiration 10/17/2023).

A total of 419 syringes were distributed nationwide in the United States under product NDC 71286-4036-1.

Patients and healthcare providers should not use the affected product. Individuals who have received this medication should contact their healthcare provider for instructions on obtaining replacement medication or further guidance.

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
Hazard
  • sterility-failure

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 (4)

  • Lot: 17-275475
  • Exp. 10/4/2023
  • 17-276117
  • Exp. 10/17/2023

Distribution

Distributed nationwide across the United States.