Recalls / Class III
Class IIID-0699-2017
Product
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.
- Affected lot / code info
- Lot #: JKP2751A, Exp 05/17; JKR5048A, Exp 04/18
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 60 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-03-22
- FDA classified
- 2017-05-10
- Posted by FDA
- 2017-05-17
- Terminated
- 2018-07-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0699-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.