Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
Dr. Reddy's is recalling 12,579 bottles of Atorvastatin Calcium 40 mg tablets because they failed impurity specifications during stability testing.
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 12,579 bottles of Atorvastatin Calcium Tablets 40 mg, 90 count. The product is prescription-only and was manufactured by Dr. Reddy's Laboratories, Ltd. in Srikakulam, India. The specific lot number is T600279, with a manufacturing date of 6/2018.
The recall was initiated because the product failed impurities and degradations specifications. Specifically, out-of-specification results were observed for Total Degradation Impurities during stability testing. The agency has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDC 55111-123-05 and lot number T600279. If found, the product should be returned to the pharmacy or point of purchase for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 12,579
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 number: T600279
- 6/2018
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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