Class I · High risk
Dr. Berne's MSM DROPS 5% Solution
Non-Sterility
Dr. Berne's MSM DROPS 5% Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation 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-0036-2024 · 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.
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 cgmp deviation recalls from 2023
All cgmp deviation recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Oxygen
cGMP Deviations
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
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