Drug Enforcement D-0504-2024

Failed Impurities/Degradation Specifications

Status

Ongoing

Classification

Class III

Report Date

May 29, 2024

Termination Date

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Product Information

Product description
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Product quantity
1,176 bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
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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-0504-2024
Event ID
94535
Recall initiation date
May 1, 2024
Center classification date
May 21, 2024
Code info
Lot H2200493; Exp 6/30/2025
More code info
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