Recalls / Class III
Class IIID-0468-2017
Product
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
- Brand name
- Olanzapine
- Generic name
- Olanzapine
- Active ingredient
- Olanzapine
- Route
- Oral
- NDC
- 55111-163
- FDA application
- ANDA076255
- Affected lot / code info
- C500202
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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 5,904 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2016-10-13
- FDA classified
- 2017-02-03
- Posted by FDA
- 2017-02-15
- Terminated
- 2017-07-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0468-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.