FDA recall D-1127-2019

Product

Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.

Reason for recall

Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-03-12

Report date

2019-04-24

Termination date

2023-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1127-2019