Ondansetron Tablets USP recall: Impurity Out of Spec
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Why was Ondansetron Tablets USP recalled?
Failed Impurities/Degradation Specifications; 12 month stability time point
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 number C500691, exp 12/2016
- Product
- Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 50,280 bottles
- Distribution
- Nationwide
- Recall date
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)