Midazolam Injection Recalled Due to Lack of Sterility Assurance
SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product. Lack of sterility assurance in a parenteral medication poses a significant risk of infection and serious harm to patients who receive the contaminated product, meeting the Severe severity threshold for Class II recalls with risk of serious injury.
Plain-English summary
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), NDC 70324-102-02, due to lack of assurance of sterility. The product is a prescription medication manufactured by SterRx located at 141 Idaho Ave., Plattsburgh, NY 12903.
Approximately 36,360 bags have been distributed nationwide across the United States. The affected lot codes and dates span from November 12, 2021, through April 15, 2022, and include multiple production batches with codes such as S21065/BQA through S21385/CBS.
Patients and healthcare providers who have this product in their possession should not use it and should contact their supplier for return and replacement instructions. Healthcare facilities should check their inventory for affected lot codes and quarantine any units matching the recalled batches.
The recalled product
- Product
- Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Parenteral
- Affected units
- 36,360
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by SterRx, LLC 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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