FDA Recall D-0504-2024
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class III Ongoing 743 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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
Reason for recall
Failed Impurities/Degradation Specifications
Recall record
- Recall number
D-0504-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Recall initiated
- 2024-05-01
- Classified by FDA Center
- 2024-05-21
- FDA published
- 2024-05-29
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- SIROLIMUS
- Generic name(s)
- SIROLIMUS
- Manufacturer(s)
- Dr. Reddy's Laboratories Limited
- NDC(s)
55111-653, 55111-654- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.