FDA recall D-1129-2019

Product

Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036

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-1129-2019