Dr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable 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: This is an FDA Class III recall involving failed manufacturing specifications and impurity detection. The source text does not report any illnesses or injuries, and the hazard is related to drug quality rather than direct patient harm. Class III recalls with no reported adverse effects typically correspond to a Moderate severity level.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles (NDC 55111-121-05) manufactured in India. The recall affects lot numbers C905064 and C905065 with expiration date 07/2021. A total of 5,984 bottles were distributed nationwide in the United States.
The recall was initiated because these lots failed impurity and degradation specifications due to the presence of ATV cyclo IP and FP impurities. The product did not meet required quality standards for pharmaceutical purity.
Patients taking this medication should not stop taking their atorvastatin without consulting their healthcare provider. Consumers with affected lots should contact Dr. Reddy's Laboratories or consult their pharmacist for further guidance. Healthcare providers and patients should report any adverse events related to this product to the FDA.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Affected units
- 5,984
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 (3)
- Lot #: C905064
- C905065
- Exp. Date 07/2021
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
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