FDA recall D-0044-2025

Cipla USA, Inc. · Class II · drug

Product

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90

Reason for recall

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Distribution

USA nationwide.

Key facts

Status
Ongoing
Initiation date
2024-10-23
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0044-2025