Drug Enforcement D-0219-2024

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

Status

Terminated

Classification

Class II

Report Date

January 17, 2024

Termination Date

September 16, 2024

Product Information

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
Product quantity
8,280 bottles
Reason for recall
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E

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

Codes & Dates

Recall number
D-0219-2024
Event ID
93622
Recall initiation date
December 15, 2023
Center classification date
January 5, 2024
Code info
Lot# C2307275; Exp. January 2026
More code info
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