Drug product
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
D-1128-2019
Product summary
- Event
- Event 82421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 15 ml Bottles
- Official record key
drug-enforcement:D-1128-2019
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