Drug product
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
D-1063-2016
Product summary
- Event
- Event 74325
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,330 bottles
- Official record key
drug-enforcement:D-1063-2016
Official wording
Reason: Failed impurities/degradation: out of specification result for impurity secorapamycin.
Code information: Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification