Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
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 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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