FDA recall D-0233-2021

Allergan, PLC. · Class II · drug

Product

Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.

Reason for recall

Labeling: Missing instructions for use insert

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2020-12-30
Report date
2021-01-27
Termination date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Madison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2021