FDAClass IIJanuary 5, 2022

dilTIAZem HCl 125 mg per recall: Sterility Concern

dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC…

Why was dilTIAZem HCl 125 mg per 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?

Lots S21164/BTV, 3-Dec-21; S21191/BUU, 18-DEC-21; S21197/BUZ, 31-Dec-21; S21220/BVV, 13-Jan-22; S21271/BX0, 27-Jan-22; S21272/BXP, 28-Jan-22; S21299/BYP, 18-Fev-22; S21300/BYQ, 19-Feb-22

Product
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC…
Recalling firm
SterRx, LLC
Quantity
24300 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