PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: November 3, 2021 Initiated: October 12, 2021 #D-0068-2022

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

Reason for Recall

Failed Moisture Limits

Details

Units Affected
22,752 blister packs
Distribution
Nationwide within the United States
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 22,752 blister packs.
Why was this product recalled?
Failed Moisture Limits
Which agency issued this recall?
This recall was issued by the FDA Drug on November 3, 2021. Severity: Low. Recall number: D-0068-2022.