Dr. Reddy's Recalls Rivastigmine Tartrate Capsules Due to Cross-Contamination
Dr. Reddy's is recalling Rivastigmine Tartrate Capsules because testing detected a peak for Ranitidine, indicating cross-contamination with other products.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Rivastigmine Tartrate Capsules, USP, 1.5 mg, 60-count bottles. The recall involves 1,728 bottles distributed nationwide in the United States. The specific product affected is identified by Lot #C607323 with an expiration date of 10/18.
The recall was initiated because a Related Substances test for the Rivastigmine Tartrate Capsules showed a peak for Ranitidine. This finding indicates cross-contamination with other products during the manufacturing process. The FDA has classified this recall as Class III, which is the lowest classification level, indicating that the violation is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected Rivastigmine Tartrate Capsules and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE)
- Brand
- RIVASTIGMINE TARTRATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,728
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 #C607323
- Exp 10/18
Distribution
Distributed nationwide across the United States.
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