Drug Enforcement D-0043-2025

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

Status

Ongoing

Classification

Class II

Report Date

November 20, 2024

Termination Date

—

Product Information

Product description
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Product quantity
1,875 boxes (cipla and exlan)
Reason for recall
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Cipla USA, Inc.
Address
10 Independence Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0043-2025
Event ID
95611
Recall initiation date
October 23, 2024
Center classification date
November 12, 2024
Code info
Lot # NB240316, Exp 12/31/25
More code info
—