FDA Recall D-0456-2023

Pharmedica USA, LLC · Phoenix, AZ

Class I — life-threatening Ongoing 1185 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

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

Quantity: a) 869 bottles; b) 1035 bottles

Reason for recall

Non-Sterility

Recall record

Recall number: D-0456-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA and Worldwide through e-commerce and trade shows
Recall initiated: 2023-02-14
Classified by FDA Center: 2023-03-10
FDA published: 2023-03-15
Recalling firm: Pharmedica USA, LLC
Firm location: Phoenix, AZ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls