FDA Drug recall D-0700-2017
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…
- FDA Drug
- Class III
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class III recall of 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… by Sun Pharmaceutical Industries, citing failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0700-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-22 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0700-2017%22
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