Recalls / Class III
Class IIID-0702-2017
Product
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), 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.
- Affected lot / code info
- Lot #: a) JKR5759A, Exp 04/18; b) JKP0943A, Exp 04/17, JKR5520A, Exp 04/18; c) JKP0988A, Exp 04/17
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
- 14,784 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-0702-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.