Sun Pharmaceutical Industries, Inc. recalls Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88)…
- Recall date
- March 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0700-2017
- FDA classification
- Class III
- Brand / firm
- Sun Pharmaceutical Industries, Inc.
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
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