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

FDA recall notice · announced August 13, 2014 · Novartis Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot # PKTS, Exp 01/17
Quantity: 50 bottles
Status: Terminated
Products in this recall event:
- 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., E (D-1516-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.