FDA recall D-0219-2024

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

Reason for recall

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

Distribution

US Nationwide.

Key facts

Status: Terminated
Initiation date: 2023-12-15
Report date: 2024-01-17
Termination date: 2024-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0219-2024