Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Summary
The FDA issued a Class II for Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pha by Preferred Pharmaceuticals, Inc.. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Details
Source
Drug Recall
External ID
D-0505-2024
Action Date
2024-05-29
Status
Ongoing
Category
drug
Product Description
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Lot/Code Info: Lot #: J2022G, Exp: 01/01/2025
Quantity Affected: 66 bottles of 30 tablets
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution
Product distributed to CA, FL, OK, KS and CT
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-10
Company
Anaheim, CA
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 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 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 (Preferred Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preferred Pharmaceuticals, Inc. have FDA actions?
Preferred Pharmaceuticals, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0505-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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