Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object
Dr. Reddy's Laboratories is recalling 6,397 bottles of Atorvastatin Calcium 80 mg tablets because a foreign object was found embedded in a tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a foreign object, which is a physical defect rather than a chemical or biological contamination, and no injuries are reported in the source text.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 6,397 bottles of Atorvastatin Calcium Tablets, 80 mg, 90-count. The recall is due to a product complaint reporting a defective tablet with an embedded foreign object observed in a bottle. The affected product is identified by Lot # T800064, with an expiration date of 12/2019, and was distributed nationwide in the USA.
Consumers who have this specific lot of Atorvastatin Calcium tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,397
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 #: T800064
- Exp 12/2019
UPCs (1)
- 355111124900
Distribution
Distributed nationwide across the United States.
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