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

FDA recall notice · announced May 18, 2016 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: Nationwide
Lot/code information: Lot number C500691, exp 12/2016
Quantity: 50,280 bottles
Status: Terminated
Products in this recall event:
- Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30 (D-0841-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.