Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility.
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Reason Lack of Assurance of Sterility
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
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