Recall Enforment Report D-0457-2023

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pharmedica USA, LLC, originally initiated on 02-14-2023 for the product Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0457-202302-14-202303-15-2023Class II995 bottlesPurely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5CGMP DeviationsOngoing
D-0456-202302-14-202303-15-2023Class Ia) 869 bottles; b) 1035 bottlesPurely 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.Non-SterilityOngoing