FDAClass IIOctober 6, 2021

Morphine Sulfate Injection recall: Sterility Concern

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per…

Why was Morphine Sulfate Injection recalled?

Defective container: Cracked vials leading to lack of sterility assurance

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?

Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023

Product
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per…
Recalling firm
Fresenius Kabi USA LLC
Quantity
963000 vials
Distribution
U.S.A. Nationwide
Recall date
October 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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