Why it was recalled
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 1808051, Exp. Date 01/01/22
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1128-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 12, 2019
- FDA report date
- Apr 24, 2019
- Quantity
- 200 15 ml Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MSM Nutraceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-1128-2019, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 82421
- Address
- 2103 W Parkside Ln Ste 107
- Code information
- Lot # 1808051, Exp. Date 01/01/22
- Postal code
- 85027-1245
- Report date
- Apr 24, 2019
- Product type
- Drugs
- Recall number
- D-1128-2019
- Classification
- Class II
- Recalling firm
- MSM Nutraceuticals, LLC
- Product quantity
- 200 15 ml Bottles
- Termination date
- May 17, 2023
- Reason for recall
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 12, 2019
- Initial firm notification
- Center classification date
- Apr 15, 2019