Class II · Moderate risk Terminated
Prednisone Tablets USP
Reason Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
PredniSONE Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
What was recalled
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
- Recalling firm
- West-Ward Pharmaceutical
- NDC code
- 0054-4741-25
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0008-2017
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.
Other Prednisone recalls
See all
Class II · Moderate risk Terminated
PredniSONE Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Prednisone Tablets
Reason Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class III · Low risk Terminated
Prednisone 20 mg
Reason Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Class II · Moderate risk Terminated
Prednisone active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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