Drug recall D-1063-2016
Product
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Reason for recall
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Lots and codes
Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 9,330 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 3, 2016
- Terminated
- April 7, 2017
Related products
- Sirolimus – drug information
- NDC 55111-654 Sirolimus · Sirolimus 2 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-653 Sirolimus · Sirolimus 1 mg/1 · Dr. Reddy's Laboratories Limited