FDA Drug recall 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 sam…
- FDA Drug
- Class III
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class III recall of Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sam… by Novartis Consumer Health, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-577-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-19 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Consumer Health |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| upc | 363481684030 |
|---|---|
| upc | 363481684054 |
| code_info | Lot #'s and Expiration dates: a) 20 gm tubes: 10116298 05/31/14 10116299 05/31/14 10116300 05/31/14 10117402 07/31…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-577-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.