FDA recall D-133-2013

Product

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.

Reason for recall

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-12-05

Report date

2013-01-30

Termination date

2014-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-133-2013