FDA recall D-1516-2014

Product

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.

Reason for recall

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-30

Report date

2014-08-13

Termination date

2014-12-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suffern, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1516-2014