Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
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 Stability Specifications: Observed OOS results: eg results for colour index
Reason Lack of sterility assurance
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Reason Failed Impurities/Degradation Specifications
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