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
Reported: February 15, 2017 Initiated: October 13, 2016 #D-0468-2017
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 5,904 bottles
- Distribution
- US Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 5,904 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 15, 2017. Severity: Low. Recall number: D-0468-2017.
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