Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot # PKTS, Exp 01/17
Why it was recalled
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Old Mill Rd, N/A, Suffern, New York 10901-4106
Distribution
- Quantity
- 50 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-30
- FDA classified
- 2014-08-06
- Posted by FDA
- 2014-08-13
- Terminated
- 2014-12-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1516-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.