Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Red Eye
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Category: Eye Drops & Ophthalmic
- Recalling firm
- MSM Nutraceuticals, LLC
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1128-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by MSM Nutraceuticals, LLC
All 2019 recallsOther sterility / contamination recalls from 2019
All sterility / contamination recalls
Class II · Moderate risk
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Class II · Moderate risk
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Lack of sterility assurance.
Class II · Moderate risk
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Lack of sterility assurance.
Class II · Moderate risk
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Lack of sterility assurance.
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