Class II · Moderate risk
Purely Soothing MSM Nasal Spray
CGMP Deviations
Purely Soothing 15% MSM Drops
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
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
- Recalling firm
- Pharmedica USA, LLC
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0456-2023 · 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 Pharmedica USA, LLC
All 2023 recallsOther sterility / contamination recalls from 2023
All sterility / contamination recalls
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