Dr. Reddy's Recalls Rivastigmine Tartrate Capsules for Dissolution Failures
Dr. Reddy's Laboratories is recalling Rivastigmine Tartrate capsules because they failed to meet dissolution 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, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, such as therapeutic failure due to dissolution issues.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottles. The recall involves 2,952 bottles distributed nationwide. The specific lot number is C501342, with an expiration date of 01/2017.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate in the body. Failure to meet these specifications can result in the medication not working as intended.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE)
- Brand
- RIVASTIGMINE TARTRATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,952
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 #: C501342
- Exp 01/2017
Distribution
Distributed nationwide across the United States.
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