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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64372
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Consumer Health
City Lincoln
State NE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-19
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and Puerto Rico, and Panama. Military distribution made.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 10102312 12/31/2013 10102313 12/31/2013 10102314 12/31/2013 10102315 12/31/2013 10102316 12/31/2013 10102317 12/31/2013 10102318 12/31/2013 10102319 1/31/2014 10102320 1/31/2014 10102321 1/31/2014 10102322 1/31/2014 10102323 1/31/2014 10102324 1/31/2014 10102325 1/31/2014 10102326 1/31/2014 10102328 1/31/2014 10102329 1/31/2014 10102330 1/31/2014 10102331 1/31/2014 10102332 1/31/2014 10102337 1/31/2014 10102338 1/31/2014 10104246 2/28/2014 10104247 2/28/2014 10104248 2/28/2014 10104249 2/28/2014 10104250 2/28/2014 10104251 2/28/2014 10104252 2/28/2014 10104257 2/28/2014 10104258 2/28/2014 10104259 2/28/2014 10104260 2/28/2014 10104261 2/28/2014 10104262 2/28/2014 10107735 2/28/2014 10107736 3/31/2014 10107737 3/31/2014 10107738 3/31/2014 10107739 3/31/2014 10107740 3/31/2014 10107741 3/31/2014 10107749 3/31/2014 10107750 3/31/2014 10107751 3/31/2014 10107752 3/31/2014 10107753 3/31/2014 10107754 3/31/2014 10110430 4/30/2014 10110431 4/30/2014 10110432 4/30/2014 10110433 4/30/2014 10110434 4/30/2014 10110435 4/30/2014 10110436 4/30/2014 10110437 4/30/2014 10110438 4/30/2014 10110439 4/30/2014 10110440 4/30/2014 10110441 4/30/2014 10110442 4/30/2014 10110443 4/30/2014 10110444 4/30/2014 10111080 4/30/2014 10111081 4/30/2014 10111082 5/31/2014 10111083 5/31/2014 10113475 5/31/2014 10113476 5/31/2014 10113477 5/31/2014 10113478 5/31/2014 10113479 5/31/2014 10113480 5/31/2014 10113481 5/31/2014 10113482 5/31/2014 10113483 5/31/2014 10113484 5/31/2014 10113485 6/30/2014 10113486 6/30/2014 10113487 6/30/2014 10113488 6/30/2014 10113489 6/30/2014 10113490 6/30/2014 10115859 6/30/2014 10115860 6/30/2014 10115861 6/30/2014 10115862 6/30/2014 10115863 6/30/2014 10115864 6/30/2014 10115865 6/30/2014 10115866 6/30/2014 10115867 6/30/2014 10115868 6/30/2014 10115869 6/30/2014 10115870 6/30/2014 10115871 7/31/2014 10115872 7/31/2014 10115873 7/31/2014 10115876 7/31/2014 10115877 7/31/2014 10115878 7/31/2014 10117411 7/31/2014 10117413 7/31/2014 10117414 7/31/2014 10117416 7/31/2014 10117417 7/31/2014 10119416 9/30/2014 10119417 9/30/2014 10119418 9/30/2014 10119419 9/30/2014 10119420 9/30/2014 10119429 9/30/2014 10119430 9/30/2014 10119431 9/30/2014 10119432 9/30/2014 10119433 10/31/2014 10119434 10/31/2014 10120546 8/31/2014 10120547 8/31/2014 10120548 8/31/2014 10120549 8/31/2014 10120550 8/31/2014 10120551 8/31/2014 10120552 8/31/2014 10120553 8/31/2014 10120554 8/31/2014 10120555 9/30/2014 10120556 9/30/2014 10120557 9/30/2014 10120558 9/30/2014 100 gm/5 pack: 10085250 3/31/2013 10085251 3/31/2013 10085252 3/31/2013 10085253 3/31/2013 10085254 3/31/2013 10085255 3/31/2013 10085256 3/31/2013 10085257 3/31/2013 10085258 3/31/2013 10085259 3/31/2013 10087044 3/31/2013 10087048 3/31/2013 10087049 3/31/2013 10087050 3/31/2013 10087051 3/31/2013 10087056 3/31/2013 10087057 3/31/2013 10087058 3/31/2013 10087059 3/31/2013 10087060 3/31/2013 10087061 3/31/2013 10087062 3/31/2013 10088283 4/30/2013 10088284 4/30/2013 10088285 4/30/2013 10088286 4/30/2013 10088287 4/30/2013 10088288 4/30/2013 10088912 6/30/2013 10088913 6/30/2013 10088914 6/30/2013 10088915 6/30/2013 10088916 6/30/2013 10088917 6/30/2013 10088918 6/30/2013 10088919 6/30/2013 10088920 7/31/2013 10092286 8/31/2013 10092287 8/31/2013 10094391 8/31/2013 10094392 8/31/2013 10094393 9/30/2013 10097029 9/30/2013 10097034 9/30/2013 10098696 10/31/2013 10098705 10/31/2013 10098706 10/31/2013 10098707 11/30/2013 10100518 11/30/2013 10100519 11/30/2013 10100520 11/30/2013 10100521 11/30/2013 10100522 12/31/2013 10100523 12/31/2013 10102327 1/31/2014 10102333 1/31/2014 10102334 1/31/2014 10102335 1/31/2014 10102336 1/31/2014 10104253 2/28/2014 10104254 2/28/2014 10104255 2/28/2014 10104256 2/28/2014 10107742 3/31/2014 10107743 3/31/2014 10107744 3/31/2014 10107745 3/31/2014 10107746 3/31/2014 10107747 3/31/2014 10107748 3/31/2014 10111084 5/31/2014 10111085 5/31/2014 10111086 5/31/2014 10111087 5/31/2014 10111088 5/31/2014 10111089 5/31/2014 10111090 5/31/2014 10115874 7/31/2014 10115875 7/31/2014 10117412 7/31/2014 10117415 7/31/2014 10119409 7/31/2014 10119410 7/31/2014 10119411 7/31/2014 10119412 8/31/2014 10119413 8/31/2014 10119414 8/31/2014 10119415 8/31/2014 10119435 10/31/2014 10119436 10/31/2014 Class III 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. a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes D-577-2013
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43 Lot #: 10109590, 10111050, Exp 2/28/13. Class III 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. 41,400 Boxes D-576-2013
Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33. (12 gm) Lot numbers and Exp dates: 10109586 30-Apr-2013, 10116816 31 May 2013, 10117695 31-Jul-2013, 10120283 31-Aug-2013, 10104980 28-Feb-2013, 10108711 31-Mar-2013, 10111313 30-Apr-2013, 10111509 30-Apr-2013, 10115506 30-Jun-2013, 10117696 30-Jun-2013, 10120763 31-Aug-2013, 10122695 30-Sep-2013, 10104983 28-Feb-2013, 10108714 31-Mar-2013, 10119643 31-Jul-2013 (30 gm) Lot numbers and Exp dates: 10104979 28-Feb-2013 10108712 31-Mar-2013 10109588 30-Apr-2013 10111507 30-Apr-2013 10115133 31-May-2013 10115619 30-Jun-2013 10117694 31-Aug-2013 10120762 30-Sep-2013 10109981 31-Mar-2013 10111316 31-Mar-2013 10114223 31-May-2013 10117697 30-Jun-2013 10104982 28-Feb-2013 10108355 31-Mar-2013, 10112072 30-Apr-2013, 10112073 30-Apr-2013 10113501 31-May-2013, 10122772 31-Aug-2013 Class III 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. 818,064 (12-gm) tubes and 836,376 (30-gm) tubes D-573-2013
Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428. Lot number and exp date: 10104145 30-Apr-2013. (Vertical package) and Lot number and exp date: 10109587 30-Apr-2013, 10111508 31-May-2013; 10119095 31-Jul-2013 and 10119096 30-Sep-2013 (Horizontal package). Class III The products have illegible lot and/or expiration dates on the product container. 219,600 tubes D-575-2013
Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN. Lot numbers and exp dates: 10108716 31-Mar-2013, 10111510 30-Apr-2013, 10113801 31-May-2013, 10113839 30-Apr-2013, 10115616 31-Aug-2013 Class III 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.. 99,660 tubes D-574-2013
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