Drug 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.
D-1516-2014
Product summary
- Event
- Event 68815
- Status
- Terminated
- Classification
- Class III
- Quantity
- 50 bottles
- Official record key
drug-enforcement:D-1516-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Code information: Lot # PKTS, Exp 01/17
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.