Recalls / Class III
Class IIID-0504-2024
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
- Brand name
- Sirolimus
- Generic name
- Sirolimus
- Active ingredient
- Sirolimus
- Route
- Oral
- NDCs
- 55111-653, 55111-654
- FDA application
- ANDA201578
- Affected lot / code info
- Lot H2200493; Exp 6/30/2025
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 1,176 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-05-01
- FDA classified
- 2024-05-21
- Posted by FDA
- 2024-05-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0504-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.