Dr. Reddy's Recalls Ondansetron Tablets Due to Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling 50,280 bottles of Ondansetron Tablets USP, 4 mg, due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating involving potential but unreported harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 50,280 bottles of Ondansetron Tablets USP, 4 mg, 30 count bottles (NDC 56111-153-30). The affected product is identified by Lot number C500691 with an expiration date of 12/2016. The recall was initiated because the product failed impurities and degradation specifications at the 12-month stability time point.
The recalled medication was distributed nationwide. Ondansetron is a prescription-only medication. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers who have this specific lot of Ondansetron Tablets should contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 50,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number C500691
- exp 12/2016
Distribution
Distributed nationwide across the United States.
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