Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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, NDC 62756-551-18.
Reported: May 17, 2017 Initiated: March 22, 2017 #D-0701-2017
Product Description
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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, NDC 62756-551-18.
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 38,316 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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, NDC 62756-551-18.. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 38,316 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 17, 2017. Severity: Low. Recall number: D-0701-2017.
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