Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure
Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate tablets because they failed dissolution testing during stability checks.
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 is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute injury risk.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Clopidogrel Bisulfate tablets, USP, 300 mg, 30-count blister packs. The recall affects Lot T600530 with an expiration date of 11/18. The product was distributed nationwide in the United States.
The recall was initiated because out-of-specification results were observed for dissolution during the 18th month of stability testing. This indicates that the tablets may not dissolve at the required rate, which could affect the delivery of the medication.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the affected product.
The recalled product
- Product
- CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
- Brand
- CLOPIDOGREL BISULFATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
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 #: T600530
- Exp 11/18
Distribution
Distributed nationwide across the United States.
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