FDA recall D-0068-2022

Product

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-10-12

Report date

2021-11-03

Termination date

2023-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

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