Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53
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 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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