Dr. Reddy's Laboratories, Inc. recalls Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bac…
- Recall date
- October 13, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0468-2017
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- US 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.
Class III means the product violates regulations but is not likely to cause harm.
What 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
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