FDA recall D-577-2013

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 for recall

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.

Distribution

Nationwide and Puerto Rico, and Panama. Military distribution made.

Key facts

Status

Terminated

Initiation date

2013-02-19

Report date

2013-06-12

Termination date

2014-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-577-2013