Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratori...
FDA Recall #D-0219-2024 — Class II — December 15, 2023
Product Description
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.
Recalling Firm
Dr. Reddy's Laboratories, Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8,280 bottles
Distribution
US Nationwide.
Code Information
Lot# C2307275; Exp. January 2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated