Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Missing Label; missing label on blister card
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
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 Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Reason Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Reason Labeling: Not elsewhere classified. NDC number is incorrect on the container.
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