Agency classClass IIOur severity:Severe FDA (Drugs)·D-0300-2022·Announced 2022-01-05

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.

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: 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
Category: Drug — Injectable / Sterile Preparation
Hazard: lack-of-sterility
contamination-risk
injection-safety
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.

See all 26 products in this recall →

Same manufacturer · SterRx, LLC

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