Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit
Reason Failed Tablet/Capsule Specifications
Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
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 Tablet/Capsule Specifications
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.
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