FDAFDA · Food and drugs·Recall number D-1063-2016
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Published July 13, 2016 · Recall initiated: June 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation: out of specification result for impurity secorapamycin.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SIROLIMUS
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide
- UPC
- 0355111654018
- Lot
- Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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