FDAFDA · Food and drugs·Recall number D-0468-2017
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
Published February 15, 2017 · Recall initiated: October 13, 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 specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OLANZAPINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- US Nationwide
- Lot
- C500202
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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