Reported Feb 15, 2017 · Terminated
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited,…
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?
- Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only
- MfdBy: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
- Lot codes and dates
- C500202
- Amount recalled
- 5,904 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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