Drug 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
D-1129-2019
Product summary
- Event
- Event 82421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 30 mL bottles
- Official record key
drug-enforcement:D-1129-2019
Official wording
Reason: Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Code information: Lot # 1808051, Exp. Date 01/01/22
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility