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Class II: temporary or reversible health riskTerminated

Dr. Reddy's Laboratories Ondansetron Tablets Recall

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Risk level
Class II
Reported by FDA
May 18, 2016
Recall ID
D-0841-2016
Check your lot numberHow we source this data

Summary

Dr. Reddy's Laboratories recalled Ondansetron Tablets starting Mar 30, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0841-2016 on May 18, 2016. Reason: Failed Impurities/Degradation Specifications; 12 month stability time point. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications; 12 month stability time point

Product description

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

Lot numbers, UPCs & expiration codes

Lot number C500691, exp 12/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0841-2016
Classification
Class II
Status
Terminated
Recall initiated
Mar 30, 2016
FDA report date
May 18, 2016
Quantity
50,280 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Dr. Reddy's Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0841-2016, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
73822
Address
107 College Rd E
Code information
Lot number C500691, exp 12/2016
Postal code
08540-6623
Report date
May 18, 2016
Product type
Drugs
Recall number
D-0841-2016
Classification
Class II
Recalling firm
Dr. Reddy's Laboratories, Inc.
Product quantity
50,280 bottles
Termination date
Apr 10, 2017
Reason for recall
Failed Impurities/Degradation Specifications; 12 month stability time point
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Distribution pattern
Nationwide
Recall initiation date
Mar 30, 2016
Initial firm notification
Letter
Center classification date
May 9, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0841-2016, published May 18, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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