Key Takeaway

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30 by Dr. Reddy's Laboratories, Inc. was recalled on March 30, 2016. The hazard: Failed Impurities/Degradation Specifications; 12 month stability time point

FDA Drug Class II Terminated

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

Recalled: March 30, 2016 ~50,280 bottles units affected D-0841-2016

Description

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

Hazard / Reason

Failed Impurities/Degradation Specifications; 12 month stability time point

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Dr. Reddy's Laboratories, Inc.

Bridgewater, NJ, United States

View all 163 recalls by Dr. Reddy's Laboratories, Inc. →

Distribution

Nationwide

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Frequently Asked Questions

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