PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 24, 2019 Initiated: March 12, 2019 #D-1129-2019

Product Description

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.

Details

Recalling Firm
MSM Nutraceuticals, LLC
Units Affected
500 30 mL bottles
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
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. Recalled by MSM Nutraceuticals, LLC. Units affected: 500 30 mL bottles.
Why was this product recalled?
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 24, 2019. Severity: Moderate. Recall number: D-1129-2019.