D-1129-2019 Class II Terminated
FDA drug recall D-1129-2019 was initiated by MSM Nutraceuticals, LLC on March 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. The recall status is terminated (terminated May 17, 2023). Affected quantity: 500 30 mL bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2019
- Initiation Date
- March 12, 2019
- Termination Date
- May 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 30 mL bottles
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 1808051, Exp. Date 01/01/22