temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030
Summary
The FDA issued a Class II for temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Si by Siddha Flower Essences, LLC.. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0410-2025
Action Date
2025-05-14
Status
Ongoing
Category
drug
Product Description
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
Lot/Code Info: Lot# S22-26424D; Exp 9/27/2027
Quantity Affected: N/A
Reason for Recall
CGMP Deviations
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-28
Company
Oxnard, CA
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 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Siddha Flower Essences, LLC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siddha Flower Essences, LLC. have FDA actions?
This is the only FDA action we have on record for Siddha Flower Essences, LLC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0410-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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