Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
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 Impurities Specification: Out of specification when measuring the impurity degradant D level.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
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