FDAClass IIJune 16, 2021

Sodium Chloride 0.9% recall

Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10

Why was Sodium Chloride 0.9% recalled?

Temperature Abuse: Product exposed to temperature outside specified limits.

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 #: 20NG02095, Exp. Date October 2021

Product
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
48 cases
Distribution
Nationwide within the United States
Recall date
June 16, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls