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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Drug — Injectable Medication
- Hazard
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.
Part of a larger recall action
This product is one of 32 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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