Reported Mar 25, 2020 · Terminated
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America,…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521
Is this the product you have?
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only
- Manufactured byFresenius Medical Care North America, Waltham, MA 02451
- Lot codes and dates
Lot #: 19EG0201219EG02019Exp. Date 05/202019DG02050Exp. Date 04/2020
- Amount recalled
- 32,592 bags
Why it was recalled
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
This product could cause temporary or reversible health problems — stop using it.
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