PlainRecalls
FDA Drug Moderate Class II Terminated

PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.

Reported: February 13, 2013 Initiated: December 5, 2012 #D-149-2013

Product Description

PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.

Reason for Recall

Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.

Details

Units Affected
128,319 bottles
Distribution
Nationwide and Puerto Rico
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.. Recalled by West-ward Pharmaceutical Corp.. Units affected: 128,319 bottles.
Why was this product recalled?
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 13, 2013. Severity: Moderate. Recall number: D-149-2013.