FDAFDA · Food and drugs·Recall number D-0699-2017
Olanzapine Tablets, 2.5 mg, 1000-count bottles, 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.
Published May 17, 2017 · Recall initiated: March 22, 2017
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: out of specification results for the related substances test parameter (impurities).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: JKP2751A, Exp 05/17; JKR5048A, Exp 04/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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