Reported Jun 12, 2013 · Terminated
Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC…
Novartis Consumer Health
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novartis Consumer Health · 10401 Hwy 6 · Lincoln, NE · 68517-9626
Is this the product you have?
- Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also
- packaged 3/100-g tubes/packs (UPC code363481684030
- NDC code6348168403)
- and 5/100-g tubes/packs (UPC code363481684054
- NDC code6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ
- Lot codes and dates
- Lot #'s
- and Expiration datesa) 20
- gm tubes
1011629805/31/141011629905/31/141011630005/31/141011740207/31/141011740307/31/141011740408/31/141011740508/31/141011740608/31/141011740710/31/141011740810/31/14
- b) 100 gm tubes
10119436101194361011943710119437101194381011943810119439101194391011944010119440101194411011944110119442101194421011944310119443101194441011944410119445101194451011944610119446100
- gm/3 pack
609 of 609 codes
100852172/28/2013100852182/28/2013100852192/28/2013100852202/28/2013100852212/28/2013100852222/28/2013100852232/28/2013100852242/28/2013100852252/28/2013100852262/28/2013100852272/28/2013100852282/28/2013100852292/28/2013100852302/28/2013100852312/28/2013100852322/28/2013100852332/28/2013100852342/28/2013100852352/28/2013100852362/28/2013100852382/28/2013100852392/28/2013100852402/28/2013100852412/28/2013100852422/28/2013100852432/28/2013100852442/28/2013100852452/28/2013100852463/31/2013100852473/31/2013
- gm/5 pack
180 of 180 codes
100852503/31/2013100852513/31/2013100852523/31/2013100852533/31/2013100852543/31/2013100852553/31/2013100852563/31/2013100852573/31/2013100852583/31/2013100852593/31/2013100870443/31/2013100870483/31/2013100870493/31/2013100870503/31/2013100870513/31/2013100870563/31/2013100870573/31/2013100870583/31/2013100870593/31/2013100870603/31/2013100870613/31/2013100870623/31/2013100882834/30/2013100882844/30/2013100882854/30/2013100882864/30/2013100882874/30/2013100882884/30/2013100889126/30/2013100889136/30/2013
- Amount recalled
- a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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