Recalls / Class II
Class IID-0841-2016
Product
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
- Affected lot / code info
- Lot number C500691, exp 12/2016
Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability time point
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 50,280 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-30
- FDA classified
- 2016-05-09
- Posted by FDA
- 2016-05-18
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0841-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.