Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they contain impurities that exceed FDA specifications.
What this means for you
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 Atorvastatin Calcium tablets, 40mg, in 90-count and 500-count bottles. The recall was initiated because the product failed impurities and degradation specifications. Specifically, the tablets contain the presence of ATV cyclo IP and FP, Dihydroxy epoxy, and Dieto epoxy impurities.
The affected products are prescription-only medications manufactured by Dr. Reddy's Laboratories Limited in India and distributed nationwide in the USA. The recall covers 10,440 90-count bottles and 224,710 500-count bottles. Specific lot numbers and expiration dates are listed in the official recall notice.
Consumers with these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The FDA has classified this recall as Class III, indicating that while the product does not comply with FDA regulations, use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- 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 (1)
- a) T900406
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
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