Allergan Sales, LLC

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
0
Inspections
39
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1694-2024Class IIKeller Funnel 2, REF: HA-001, STERILEEO, Rx Only,March 14, 2024
D-1056-2019Class IICombigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only,March 19, 2019
D-0077-2018Class IIICombigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in October 19, 2017
D-0078-2018Class IIILumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612October 19, 2017
D-0929-2017Class IIBlephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterileMay 1, 2017
D-0667-2017Class IIILumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, March 16, 2017
D-0099-2017Class IITAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packagedJune 30, 2016
D-0100-2017Class IITAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, ManuJune 30, 2016
D-1064-2016Class IITazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023May 10, 2016
D-1065-2016Class IITazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238May 10, 2016
D-1819-2015Class IIFML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 926August 24, 2015
D-1818-2015Class IIRefresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz August 24, 2015
D-1817-2015Class IIRefresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged iAugust 24, 2015
D-1820-2015Class IIBLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 August 24, 2015