FDA recall D-149-2013

Product

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-12-05

Report date

2013-02-13

Termination date

2015-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-149-2013