D-1516-2014 Class III Terminated
FDA drug recall D-1516-2014 was initiated by Novartis Pharmaceuticals Corp. on Jul 30, 2014 and is designated Class III. Reason for recall: Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers. The recall status is terminated (terminated Dec 5, 2014). Affected quantity: 50 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 13, 2014
- Initiation Date
- Jul 30, 2014
- Termination Date
- Dec 5, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 bottles
Product description
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 pattern
Nationwide
Code information
Lot # PKTS, Exp 01/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1516-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026