Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz
Summary
The FDA issued a Class II for Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagi by DISCOVERY PHARMA LLC. Reason: CGMP deviations.
Details
Source
Drug Recall
External ID
D-0261-2023
Action Date
2023-02-08
Status
Terminated
Category
drug
Product Description
Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland
Lot/Code Info: Lots: 22123 Exp. 01/2024; 21732 Exp. 07/2023
Quantity Affected: 21,892 tubes
Reason for Recall
CGMP deviations
Distribution
CA, FL, WA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-09
Company
Oviedo, FL
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 108 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 (DISCOVERY PHARMA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DISCOVERY PHARMA LLC have FDA actions?
This is the only FDA action we have on record for DISCOVERY PHARMA LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0261-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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