FDAClass IIJanuary 5, 2022

Fentanyl Citrate recall: Sterility Concern

Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC…

Why was Fentanyl Citrate 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?

S21349/CAI 23-Mar-22 S21356/CAP 1-Apr-22 S21361/CAU 2-Apr-22

Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC…
Recalling firm
SterRx, LLC
Quantity
10660 bags
Distribution
U.S.A. Nationwide
Recall date
January 5, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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