TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine,
FDA recall notice · announced October 19, 2016 · Allergan Sales
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
Reason for recall
Failed Content Uniformity Specifications
Notes
Distribution: Nationwide
Lot/code information: a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17
Quantity: 25,247 tubes (19,499 30 gram/ 5,748 100 gram)
Status: Terminated
Products in this recall event:
- TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159. (D-0100-2017)
- TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: (D-0099-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.