Recalls / Class III
Class IIID-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
- Brand name
- Sirolimus
- Generic name
- Sirolimus
- Active ingredient
- Sirolimus
- Route
- Oral
- NDCs
- 55111-653, 55111-654
- FDA application
- ANDA201578
- Affected lot / code info
- Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
Why it was recalled
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 9,330 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-03
- FDA classified
- 2016-07-05
- Posted by FDA
- 2016-07-13
- Terminated
- 2017-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1063-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.