Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India,…
Dr. Reddy's Laboratories, Inc. · Failed Impurities/Degradation Specifications
- Status
- Ongoing
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Class III
- Product type
- Drugs
- Event ID
- 94535
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Address 1
- 107 College Rd E
- Postal code
- 08540-6623
- Voluntary mandated
- Voluntary: Firm initiated
- Distribution pattern
- US Nationwide.
- Recall number
- D-0504-2024
- 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 date
- 20240501
- Center classification date
- 20240521
- Report date
- 20240529
- Code info
- Lot H2200493; Exp 6/30/2025
- Harmonized identifiers (openFDA)
- Application number
- ANDA201578
- Brand name
- SIROLIMUS
- Generic name
- SIROLIMUS
- Manufacturer name
- Dr. Reddy's Laboratories Limited
- Product NDC
- 55111-653, 55111-654
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- SIROLIMUS
- RxCUI
- 349208, 360110
- SPL ID
- f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b
- SPL set ID
- 2e6130e5-fa94-dcf8-605c-817bf396e93d
- Package NDC
- 55111-653-30, 55111-653-01, 55111-654-30, 55111-654-01
- Is original packager
- true
- Upc
- 0355111654018
- Nui
- N0000175550, N0000175625, N0000175624, N0000175605, N0000175076
- Pharm class pe
- Decreased Immunologic Activity [PE]
- Pharm class epc
- mTOR Inhibitor Immunosuppressant [EPC], Kinase Inhibitor [EPC]
- Pharm class moa
- mTOR Inhibitors [MoA], Protein Kinase Inhibitors [MoA]
- UNII
- W36ZG6FT64