Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
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 Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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