Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-
Summary
The FDA issued a Class II for Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), by Northwind Pharmaceuticals LLC. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0553-2023
Action Date
2023-05-03
Status
Ongoing
Category
drug
Product Description
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Lot/Code Info: a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
Quantity Affected: a)164 bottles; b) 198 bottles
Reason for Recall
CGMP Deviations
Distribution
Nationwide with the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-16
Company
Indianapolis, IN
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 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Northwind Pharmaceuticals LLC has 8 FDA actions in our database, including 8 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 (Northwind Pharmaceuticals LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Northwind Pharmaceuticals LLC have FDA actions?
Northwind Pharmaceuticals LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0553-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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