Reported Jul 13, 2016 · Terminated
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam -…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Sirolimus Tablets, 1 mg, 100-count bottle, Rx only
- Manufactured by
Dr. Reddy's Laboratories LimitedVisakhapatnam - 5300046 IndiaNDC 55111-653-01
- Lot codes and dates
Lot # H400044H400045Exp 07/16H400048Exp 08/16H400055Exp 10/16H400070H400071H400073 and H400074Exp 11/16
- Amount recalled
- 9,330 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/degradation: out of specification result for impurity secorapamycin.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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