Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets because stability testing showed out-of-specification results for total degradation impurities.
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 10 mg, a prescription medication manufactured in Srikakulam, India. The recall involves 90-count and 500-count bottles distributed nationwide. The specific lot numbers affected are T600125 (manufactured March 2018), T600201 (manufactured May 2018), and T600248 (manufactured May 2018).
The recall was initiated because out-of-specification results were observed for Total Degradation Impurities during stability testing. This indicates that the product failed to meet the required specifications for impurities and degradations.
The FDA has classified this recall as Class III, which means that use of, or exposure to, the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or Dr. Reddy's Laboratories for further instructions or a replacement.
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 (7)
- Lot numbers: a) T600125
- 3/2018
- T600201
- T600248 5/2018
- b) T600125
- and T600248
- 5/2018
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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