Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)
Summary
The FDA issued a Class III for Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, E by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Failed Moisture Limits.
Details
Source
Drug Recall
External ID
D-0068-2022
Action Date
2021-11-03
Status
Terminated
Category
drug
Product Description
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Lot/Code Info: Lot #: AC14635, Exp. Date 12/2022
Quantity Affected: 22,752 blister packs
Reason for Recall
Failed Moisture Limits
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-12
Company
Princeton, 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 84 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
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 (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0068-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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