Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA…
Reason Lack of Assurance of Sterility.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of assurance of sterility.
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
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 Lack of Assurance of Sterility.
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
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