Allergan Sales, LLC Recalls

All product recalls associated with Allergan Sales, LLC.

Get alerts for this brand

Recall Summary

Total Recalls

14

Past Year

0

Class I (Serious)

0

Most Recent

Mar 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–14 of 14 recalls

Keller Funnel 2 (Allergan) – Implant Coating Issue (2024)

Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

Moderate

FDAMar 14, 2024Nationwide• Allergan Sales, LLC

Combigan Eye Solution (Allergan) – Manufacturing Deviation (2019)

cGMP Deviations

Class IIModerate

FDAMar 19, 2019TN• Allergan Sales, LLC

Lumigan Eye Solution (Allergan) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAOct 19, 2017

Nationwide

• Allergan Sales, LLC

Combigan Eye Solution (Allergan) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAOct 19, 2017Nationwide• Allergan Sales, LLC

Blephamide Ophthalmic Ointment (Allergan) – Impurity Issue (2017)

Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.

Class IIModerate

FDAMay 1, 2017Nationwide• Allergan Sales, LLC

Lumigan (Allergan) – Failed Impurities (2017)

Failed Impurities/Degradation Specifications

Class IIILow

FDAMar 16, 2017Nationwide• Allergan Sales, LLC

TAZORAC Dermatologic Gel (Allergan) – Content Uniformity Issue (2016)

Failed Content Uniformity Specifications

Class IIModerate

FDAJun 30, 2016Nationwide• Allergan Sales, LLC

TAZORAC Gel 0.05% (Allergan) – Content Uniformity Issue (2016)

Failed Content Uniformity Specifications

Class IIModerate

FDAJun 30, 2016Nationwide• Allergan Sales, LLC

Tazorac Gel 0.05% (Allergan) – Content Uniformity Failure (2016)

Failed Content Uniformity Specifications.

Class IIModerate

FDAMay 10, 2016Nationwide• Allergan Sales, LLC

Tazorac Gel (Allergan) – Failed Content Uniformity (2016)

Failed Content Uniformity Specifications.

Class IIModerate

FDAMay 10, 2016Nationwide• Allergan Sales, LLC

Refresh Lacri-Lube (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

FML Ophthalmic Ointment (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Blephamide Ophthalmic Ointment (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Refresh P.M. Eye Ointment (Allergan) – particulate matter contamination (2015)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Class IIModerate

FDAAug 24, 2015Nationwide• Allergan Sales, LLC

Stay Informed

Allergan Sales, LLC Recalls

Recall Summary

Keller Funnel 2 (Allergan) – Implant Coating Issue (2024)

Combigan Eye Solution (Allergan) – Manufacturing Deviation (2019)

Lumigan Eye Solution (Allergan) – Impurity Specification Failure (2017)

Combigan Eye Solution (Allergan) – Impurity Specification Failure (2017)

Blephamide Ophthalmic Ointment (Allergan) – Impurity Issue (2017)

Lumigan (Allergan) – Failed Impurities (2017)

TAZORAC Dermatologic Gel (Allergan) – Content Uniformity Issue (2016)

TAZORAC Gel 0.05% (Allergan) – Content Uniformity Issue (2016)

Tazorac Gel 0.05% (Allergan) – Content Uniformity Failure (2016)

Tazorac Gel (Allergan) – Failed Content Uniformity (2016)

Refresh Lacri-Lube (Allergan) – particulate matter contamination (2015)

FML Ophthalmic Ointment (Allergan) – particulate matter contamination (2015)

Blephamide Ophthalmic Ointment (Allergan) – particulate matter contamination (2015)

Refresh P.M. Eye Ointment (Allergan) – particulate matter contamination (2015)