SterRx Midazolam Injection Recalled for Lack of Sterility Assurance
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Midazolam is a potent sedative/anxiolytic drug administered by injection, and lack of sterility assurance creates risk of serious infection or adverse medical events requiring hospitalization, meeting the Severe criterion for Class II recalls with risk of serious harm.
Plain-English summary
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), NDC #70324-102-01, distributed nationwide. The recall is due to lack of assurance of sterility.
The recall affects 15,660 bags from the following lots: S21131/BSP (10-Nov-21), S21132/BSQ (11-Nov-21), S21139/BSX (18-Nov-21), S21150/BTI (24-Nov-21), S21158/BTP (1-Dec-21), S21160/BTR (2-Dec-21), and S21170/BUB (9-Dec-21).
Patients and healthcare providers who have this product should not use it and should contact their pharmacy or healthcare provider for guidance on alternative treatments. Patients should consult their physician before discontinuing use of the recalled product.
The recalled product
- Product
- Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
- Manufacturer
- SterRx, LLC
- Affected units
- 15,660
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 (8)
- Lots S21131/BSP
- 10-Nov-21 S21132/BSQ
- 11-Nov-21 S21139/BSX
- 18-Nov-21 S21150/BTI
- 24-Nov-21 S21158/BTP
- 1-Dec-21 S21160/BTR
- 2-Dec-21 & S21170/BUB
- 9-Dec-21.
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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