FDAFDA · Food and drugs·Recall number D-577-2013

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 code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.

Published June 12, 2013 · Recall initiated: February 19, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Novartis Consumer Health
Distributor: Nationwide and Puerto Rico, and Panama. Military distribution made.
Lot: Lot #'s and Expiration dates: a) 20 gm tubes: 10116298 05/31/14 10116299 05/31/14 10116300 05/31/14 10117402 07/31/14 10117403 07/31/14 10117404 08/31/14 10117405 08/31/14 10117406 08/31/14 10117407 10/31/14 10117408 10/31/14 b) 100 gm tubes: 10119436 10119436 10119437 10119437 10119438 10119438 10119439 10119439 10119440 10119440 10119441 10119441 10119442 10119442 10119443 10119443 10119444 10119444 10119445 10119445 10119446 10119446 100 gm/3 pack: 10085217 2/28/2013 10085218 2/28/2013 10085219 2/28/2013 10085220 2/28/2013 10085221 2/28/2013 10085222 2/28/2013 10085223 2/28/2013 10085224 2/28/2013 10085225 2/28/2013 10085226 2/28/2013 10085227 2/28/2013 10085228 2/28/2013 10085229 2/28/2013 10085230 2/28/2013 10085231 2/28/2013 10085232 2/28/2013 10085233 2/28/2013 10085234 2/28/2013 10085235 2/28/2013 10085236 2/28/2013 10085238 2/28/2013 10085239 2/28/2013 10085240 2/28/2013 10085241 2/28/2013 10085242 2/28/2013 10085243 2/28/2013 10085244 2/28/2013 10085245 2/28/2013 10085246 3/31/2013 10085247 3/31/2013 10085248 3/31/2013 10085249 3/31/2013 10085260 3/31/2013 10085261 3/31/2013 10085262 3/31/2013 10085263 3/31/2013 10085264 3/31/2013 10085265 3/31/2013 10085266 3/31/2013 10085267 3/31/2013 10085268 3/31/2013 10085269 3/31/2013 10085270 3/31/2013 10085271 3/31/2013 10085272 3/31/2013 10087039 3/31/2013 10087040 3/31/2013 10087041 3/31/2013 10087042 3/31/2013 10087043 3/31/2013 10087052 3/31/2013 10087053 3/31/2013 10087054 3/31/2013 10087055 3/31/2013 10087063 3/31/2013 10087064 3/31/2013 10087065 3/31/2013 10088276 4/30/2013 10088277 4/30/2013 10088278 4/30/2013 10088279 4/30/2013 10088280 4/30/2013 10088281 4/30/2013 10088282 4/30/2013 10088289 4/30/2013 10088290 4/30/2013 10088291 4/30/2013 10088292 4/30/2013 10088293 4/30/2013 10088294 4/30/2013 10088295 4/30/2013 10088296 4/30/2013 10088297 4/30/2013 10088298 4/30/2013 10088299 4/30/2013 10088300 4/30/2013 10088301 4/30/2013 10088302 4/30/2013 10088303 4/30/2013 10088304 4/30/2013 10088305 4/30/2013 10088306 4/30/2013 10088307 4/30/2013 10088308 4/30/2013 10088309 4/30/2013 10088310 4/30/2013 10088311 4/30/2013 10088312 4/30/2013 10088313 4/30/2013 10088314 4/30/2013 10088315 4/30/2013 10088897 5/31/2013 10088898 5/31/2013 10088899 5/31/2013 10088900 5/31/2013 10088901 5/31/2013 10088902 5/31/2013 10088903 5/31/2013 10088904 5/31/2013 10088905 5/31/2013 10088906 5/31/2013 10088907 5/31/2013 10088908 5/31/2013 10088909 5/31/2013 10088910 5/31/2013 10088911 6/30/2013 10088921 7/31/2013 10088922 7/31/2013 10088923 7/31/2013 10088924 7/31/2013 10088925 7/31/2013 10088926 7/31/2013 10088927 7/31/2013 10088928 7/31/2013 10088929 7/31/2013 10088930 7/31/2013 10088931 7/31/2013 10090306 4/30/2013 10090307 4/30/2013 10090308 4/30/2013 10092277 7/31/2013 10092278 7/31/2013 10092279 7/31/2013 10092280 7/31/2013 10092281 7/31/2013 10092282 7/31/2013 10092283 7/31/2013 10092284 8/31/2013 10092285 8/31/2013 10092288 8/31/2013 10092289 8/31/2013 10092290 8/31/2013 10092291 8/31/2013 10092292 8/31/2013 10092293 8/31/2013 10092294 8/31/2013 10094387 8/31/2013 10094388 8/31/2013 10094389 8/31/2013 10094390 8/31/2013 10094394 9/30/2013 10094395 9/30/2013 10094396 9/30/2013 10094397 9/30/2013 10094398 9/30/2013 10097030 9/30/2013 10097031 9/30/2013 10097032 9/30/2013 10097033 9/30/2013 10097035 10/31/2013 10097036 10/31/2013 10098681 10/31/2013 10098692 10/31/2013 10098693 10/31/2013 10098694 10/31/2013 10098695 10/31/2013 10098697 10/31/2013 10098698 10/31/2013 10098699 10/31/2013 10098700 10/31/2013 10098701 10/31/2013 10098702 10/31/2013 10098703 10/31/2013 10098704 10/31/2013 10098708 11/30/2013 10098709 11/30/2013 10100515 11/30/2013 10100516 11/30/2013 10100517 11/30/2013 10100524 12/31/2013 10100525 12/31/2013 10100526 12/31/2013 10100527 12/31/2013 10100528 12/31/2013 1010
Risk classification: Class III
Area (FDA): drug
Country: United States

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