Class I — High risk. Reasonable probability of serious harm or death.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
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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