Olanzapine Tablets recall: Impurity Out of Spec
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.
Why was Olanzapine Tablets recalled?
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) JKP3150B, Exp 06/17, JKR5749A, Exp 06/18; b) JKP2757A, Exp 05/17, JKP3149A, JKP3150A, Exp 06/17, JKR5049A, Exp 04/18; c) JKP2758B, Exp 05/17
- Product
- 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.
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Quantity
- 6,138 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- May 17, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)