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Recall Observatory FDA recall evidence

Drug product

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.

D-0456-2023

February 14, 2023

Class I

Product summary

Firm
Pharmedica USA, LLC
Event
Event 91707
Status
Ongoing
Classification
Class I
Quantity
a) 869 bottles; b) 1035 bottles
Official record key
drug-enforcement:D-0456-2023

Official wording

Reason: Non-Sterility

Code information: Lot #s: a) 1808051, Exp.: 01/01/2027; b) 2203PS01, Exp.: 01/01/2027

Distribution pattern: Nationwide in the USA and Worldwide through e-commerce and trade shows

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility