Novartis Recalls Cataflam Tablets Due to Illegible Ink Identification
Novartis is recalling 50 bottles of Cataflam (diclofenac potassium) 50 mg tablets because ink identification rubbed off during transit, making them illegible.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a cosmetic/legibility defect rather than a safety hazard.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling 50 bottles of Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles. The product is prescription-only and was distributed nationwide. The specific lot affected is # PKTS with an expiration date of 01/17.
The recall was initiated because ink identification rubbed off the tablets during transit. This defect makes the tablets illegible to pharmacists and consumers. The agency has classified this as a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and pharmacists should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or disposed of according to local regulations. No specific instructions for consumers who may have already taken the medication are provided in the source text.
The recalled product
- 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.
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # PKTS
- Exp 01/17
Distribution
Distributed nationwide across the United States.
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