Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Summary
The FDA issued a Class II for Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint by Consolidated Chemical, Inc. Reason: CGMP Deviations: initiated due to violations of CGMP manufacturing practices.
Details
Source
Drug Recall
External ID
D-0326-2023
Action Date
2023-02-22
Status
Ongoing
Category
drug
Product Description
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Lot/Code Info: Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
Quantity Affected: 3186 bottles
Reason for Recall
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-10
Company
Saint Louis, MO
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 73 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Consolidated Chemical, Inc 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 (Consolidated Chemical, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Consolidated Chemical, Inc have FDA actions?
Consolidated Chemical, Inc 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-0326-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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