Class II · Moderate risk
Dr. Berne's MSM DROPS 5% Solution
CGMP Deviations
Dr. Berne's MSM DROPS 5% Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility
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
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
- Recalling firm
- Dr. Berne's Whole Health Products
- Origin
- NM, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0037-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by Dr. Berne's Whole Health Products
All 2023 recalls
Class II · Moderate risk
Dr. Berne's Organic Castor Oil Eye Drops
CGMP Deviations
Class II · Moderate risk
Dr. Berne's MSM MIST 15% Solution
CGMP Deviations
Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
CGMP Deviations
Other sterility / contamination recalls from 2023
All sterility / contamination recalls
Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Lack of Sterility Assurance
Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Class I · High risk
Rugby brand Lubricating Tears Eye Drops
Non-Sterility
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