Drug Enforcement D-133-2013

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.

Status

Terminated

Classification

Class II

Report Date

January 30, 2013

Termination Date

May 16, 2014

Product Information

Product description
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.
Product quantity
60,289 bottles
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
West-ward Pharmaceutical Corp.
Address
465 Industrial Way W, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-133-2013
Event ID
63971
Recall initiation date
December 5, 2012
Center classification date
January 18, 2013
Code info
Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15
More code info
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