The Recall Desk
SevereFDA (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.

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

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.

Related recalls

Same category