Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
Dr. Reddy's is recalling 40 mg Atorvastatin Calcium tablets because stability testing showed impurity levels exceeding specifications.
What this means for you
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 III, which indicates the product is unlikely to cause adverse health consequences. The issue is a failure of impurity specifications without reported injuries.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 2,280 bottles of Atorvastatin Calcium tablets, 40 mg, 500-count. The affected product is identified by NDC 55111-123-05 and code T60045. The recall covers distribution across the United States.
The recall was initiated because out-of-specification (OOS) results were observed for ATV Cyclo FP Impurity and Total Degradation Impurities during testing at the 18-month stability time point. This indicates the product failed to meet established impurity and degradation specifications.
Consumers and healthcare providers with this specific product should stop using it and contact their pharmacist or Dr. Reddy's Laboratories for instructions on return or replacement.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,280
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 (1)
- T60045
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
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