Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets due to the presence of degradation impurities.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 2,980 bottles of Atorvastatin Calcium Tablets, USP 10 mg. The affected product is identified by Lot # C905063 and has an expiration date of 07/2021. The NDC for the recalled 500-count bottles is 55111-121-05.
The recall was initiated because the product failed impurity degradation specifications due to the presence of ATV cyclo IP and FP impurities. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- 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 # C905063
- Exp 07/2021
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
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