Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Summary
The FDA issued a Class II for Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake li.
Details
Source
Drug Recall
External ID
D-0212-2025
Action Date
2025-02-05
Status
Terminated
Category
drug
Product Description
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Lot/Code Info: Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
Quantity Affected: a) 6408 boxes and b)1488 boxes
Reason for Recall
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-13
Company
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 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 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 (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories have FDA actions?
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0212-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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