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 bott
Summary
The FDA issued a Class I for Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 by Pharmedica USA, LLC. Reason: Non-Sterility.
Details
Source
Drug Recall
External ID
D-0456-2023
Action Date
2023-03-15
Status
Ongoing
Category
drug
Product Description
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 Info: Lot #s: a) 1808051, Exp.: 01/01/2027; b) 2203PS01, Exp.: 01/01/2027
Quantity Affected: a) 869 bottles; b) 1035 bottles
Reason for Recall
Non-Sterility
Distribution
Nationwide in the USA and Worldwide through e-commerce and trade shows
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-14
Company
Phoenix, AZ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pharmedica USA, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pharmedica USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pharmedica USA, LLC have FDA actions?
Pharmedica USA, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0456-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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