FDA-Drug2021-11-03Class III

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Moisture Limits

Sold states
Nationwide within the United States
Affected count
22,752 blister packs
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0068-2022

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