Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Mislabeling: preservative free product labeled as preserved.
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
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 Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter: Presence of glass particulates.
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
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