FDAClass IIJanuary 5, 2022

Midazolam in 0.9% Sodium Chloride Injection recall: Sterility Concern

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…

Why was Midazolam in 0.9% Sodium Chloride Injection recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

S21065/BQA 12-Nov-21 S21066/BQB 19-Nov-21 S21142/BTA 19-Nov-21 S21143/BTB 20-Nov-21 S21146/BTE 21-Nov-21 S21147/BTF 25-Nov-21 S21148/BTG 25-Nov-21 S21153/BTL 26-Nov-21 S21154/BTM 27-Nov-21 S21171/BUC 10-Dec-21 S21172/BUD 11-Dec-21 S21173/BUE 15-Dec-21 S21190/BUT 16-Dec-21 S21201/BVD 22-Dec-21 S21202/BVE 24-Dec-21 S21203/BVF 29-Dec-21 S21204/BVG 19-Jan-22 S21258/BXD 20-Jan-22 S21275/BXS 30-Jan-22 S21276/BXT 2-Feb-22 S21277/BXU 3-Feb-22 S21278/BXV 3-Feb-22 S21284/BYB 4-Feb-22 S21285/BYC 5-Feb-22 S21286/BYD 11-Feb-22 S21287/BYE 12-Feb-22 S21290/BYH 16-Feb-22 S21304/BYT 23-Feb-22 S21306/BYV 24-Feb-22 S21308/BYX 25-Feb-22 S21310/BYZ 26-Feb-22 S21379/CBM 14-Apr-22 S21382/CBP 14-Apr-22 S21385/CBS 15-Apr-22

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…
Recalling firm
SterRx, LLC
Quantity
36360 bags
Distribution
U.S.A. Nationwide
Recall date
January 5, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls