Why it was recalled
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
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.
Lot numbers, UPCs & expiration codes
Lot # PKTS, Exp 01/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1516-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 30, 2014
- FDA report date
- Aug 13, 2014
- Quantity
- 50 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1516-2014, exactly as published.
Show all FDA fields
- City
- Suffern
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68815
- Address
- 25 Old Mill Rd
- Code information
- Lot # PKTS, Exp 01/17
- Postal code
- 10901-4106
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1516-2014
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 50 bottles
- Termination date
- Dec 5, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 30, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2014