Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
Dr. Reddy's is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component was found to be 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 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 Amlodipine Besylate and Atorvastatin Calcium Tablets, 10 mg/80 mg, 30 Count Bottles. The recall is due to the atorvastatin component being subpotent, meaning it does not contain the full labeled amount of the active ingredient.
The affected product is identified by Lot # C404595 and has an expiration date of 11/2015. The NDC for the recalled 30-count bottles is 43598-313-30. A total of 3,840 bottles were distributed nationwide in the United States.
The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lot and return it to the pharmacy or contact Dr. Reddy's Laboratories for further instructions.
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
- 3,840
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 #: C404595
- Expiry: 11/2015
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
- ModerateDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
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