Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
Dr. Reddy's Laboratories is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain subpotent atorvastatin.
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, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Amlodipine Besylate and Atorvastatin Calcium Tablets, 5 mg/20 mg, in 30-count and 90-count bottles. The recall involves Lot # C403577 with an expiration date of 10/2015. The affected products were distributed nationwide in the United States.
The recall was initiated because the tablets contain subpotent atorvastatin, meaning the medication does not contain the full amount of the active ingredient required by the label. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Patients who have been prescribed this medication should contact their healthcare provider or pharmacist for guidance. They should not stop taking their medication without consulting a medical professional. The recall number is D-1376-2015.
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
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 (4)
- a) Lot #: C403577
- Expiry: 10/2015
- b) Lot #: C403577
- 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
- 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
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
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