PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 16, 2021 Initiated: April 28, 2021 #D-0603-2021

Product Description

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

Reason for Recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Details

Units Affected
48 cases
Distribution
Nationwide within the United States
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 48 cases.
Why was this product recalled?
Temperature Abuse: Product exposed to temperature outside specified limits.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 16, 2021. Severity: Moderate. Recall number: D-0603-2021.