FDA-Drug2013-01-30Class II
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
West-ward Pharmaceutical Corp.
Hazard
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Sold states
Nationwide and Puerto Rico
Affected count
60,289 bottles
Manufactured in
465 Industrial Way W, N/A, Eatontown, NJ, United States
Products
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-133-2013Don't want to check this manually?
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