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Recall Observatory FDA recall evidence

Drug 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

D-0457-2023

February 14, 2023

Class II

Product summary

Firm
Pharmedica USA, LLC
Event
Event 91707
Status
Ongoing
Classification
Class II
Quantity
995 bottles
Official record key
drug-enforcement:D-0457-2023

Official wording

Reason: CGMP Deviations

Code information: Lot #: 1808051, Exp.: 01/01/2027

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations