Recall: D-0068-2022

Class III - Minor Violations

Class IIIClassification

2021-10-12Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Failed Moisture Limits

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.