Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix,
Summary
The FDA issued a Class II for Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Ma by Pharmedica USA, LLC. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0457-2023
Action Date
2023-03-15
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 1808051, Exp.: 01/01/2027
Quantity Affected: 995 bottles
Reason for Recall
CGMP Deviations
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 II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0457-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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