Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Summary
The FDA issued a Class III for Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured b by Appco Pharma LLC. Reason: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet.
Details
Source
Drug Recall
External ID
D-0208-2025
Action Date
2025-01-29
Status
Completed
Category
drug
Product Description
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Lot/Code Info: Lot #: 2402101UR, Exp 02/28/2027
Quantity Affected: 1380 bottles
Reason for Recall
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Distribution
Nationwide USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-16
Company
Piscataway, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 114 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Appco Pharma LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Appco 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 Appco Pharma LLC have FDA actions?
Appco Pharma LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0208-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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