Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
Dr. Reddy's Laboratories is recalling 576 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.
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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 576 bottles of Amlodipine Besylate and Atorvastatin Calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles. The recall is due to the presence of subpotent atorvastatin in the product. The affected product is identified by Lot # C403574 and has an expiration date of 10/2015.
The product was distributed nationwide in the United States. It is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India. The FDA has classified this recall as Class III, indicating 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 product and contact their healthcare provider or pharmacist for further instructions. The recall number is D-1374-2015.
The recalled product
- Product
- AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
- Brand
- AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 576
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 #: C403574
- Expiry: 10/2015
UPCs (9)
- 0343598323305
- 0343598315300
- 0343598320304
- 0343598317304
- 0343598313306
- 0343598322308
- 0343598319308
- 0343598316307
- 0343598314303
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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 7 products in this recall →Related recalls
Same brand · AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- ModerateDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- ModerateDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
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