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Allergan Sales, LLC

Allergan Sales, LLC Recalls

All product recalls associated with Allergan Sales, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

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 1–20 of 44 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

Refresh Relieva Eye Drops (Allergan) – Missing Instructions (2020)

Labeling: Missing instructions for use insert

Class IIModerate

FDADec 30, 2020Nationwide• Allergan, PLC.

Allergan PLC: REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12...

Missing Instruction For Use insert.

FDADec 29, 2020MO• Allergan PLC

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Skin Medica Acne System (Allergan) – Potency Failure (2020)

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

Class IIILow

FDAJul 6, 2020Nationwide• Allergan PLC

Skin Medica Acne Treatment Lotion (Allergan) – Potency Failure (2020)

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

Class IIILow

FDAJul 6, 2020Nationwide• Allergan PLC

Allergan PLC: NATRELLE Resterilizable Sizers for the styles and sizes: ...

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

FDANov 6, 2019AL, AZ, AR +44 more• Allergan PLC

Allergan PLC: XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, ...

Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.

FDAOct 30, 2019Nationwide• Allergan PLC

Allergan PLC: McGhan BioDIMENSIONAL silicone-Filled Breast Implants, st...

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

FDAJul 24, 2019Nationwide• Allergan PLC