Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
Summary
The FDA issued a Class II for Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York by Homeocare Laboratories, Inc.. Reason: cGMP deviations.
Details
Source
Drug Recall
External ID
D-0881-2023
Action Date
2023-07-05
Status
Terminated
Category
drug
Product Description
Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
Lot/Code Info: Lot # 2446, exp. Mar-24
Quantity Affected: 2,376 bottles
Reason for Recall
cGMP deviations
Distribution
Product was distributed USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-05
Company
Yonkers, NY
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 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Homeocare Laboratories, Inc. has 13 FDA actions in our database, including 13 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 (Homeocare Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Homeocare Laboratories, Inc. have FDA actions?
Homeocare Laboratories, Inc. has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0881-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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