Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Reported: May 18, 2016 Initiated: March 30, 2016 #D-0841-2016
Product Description
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Reason for Recall
Failed Impurities/Degradation Specifications; 12 month stability time point
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 50,280 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 50,280 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; 12 month stability time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 18, 2016. Severity: Moderate. Recall number: D-0841-2016.
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