Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Tablet/Capsule Specifications
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
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 Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Product found to be Sub Potent or Exceeded reconstitution time
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
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