Home / Recalls / Allergan Sales, LLC / D-0099-2017

D-0099-2017 Class II Terminated

Recalled by Allergan Sales, LLC — Waco, TX

Recall Details

Product Type: Drugs
Report Date: October 19, 2016
Initiation Date: June 30, 2016
Termination Date: December 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25,247 tubes (19,499 30 gram/ 5,748 100 gram)

Product Description

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

Distribution Pattern

Nationwide

Code Information

a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/17

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D-0078-2018 Class III — Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allerg (October 19, 2017)
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D-0929-2017 Class II — Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, U (May 1, 2017)
D-0667-2017 Class III — Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allerga (March 16, 2017)
D-0100-2017 Class II — TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sam (June 30, 2016)
D-1064-2016 Class II — Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) a (May 10, 2016)
D-1065-2016 Class II — Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, (May 10, 2016)
D-1819-2015 Class II — FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, I (August 24, 2015)