FDA recall D-0090-2019

Product

ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05

Reason for recall

Lack of Process Controls

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-08-10

Report date

2018-10-31

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0090-2019