FDA recall D-0069-2022

SUN PHARMACEUTICAL INDUSTRIES INC · Class III · drug

Product

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

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-0069-2022