Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
Dr. Reddy's 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 as a Class III recall, 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/40 mg, due to the presence of subpotent atorvastatin. The affected products are packaged in 30-count and 90-count bottles and were distributed nationwide in the United States.
The recall involves specific lots: C409650 and C409652, both with an expiration date of 05/2016. The total quantity recalled is 16,848 bottles of the 30-count size and 216 bottles of the 90-count size. The agency has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India.
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 #: C409650
- Expiry: 05/2016
- Lot #: C409652
- Expiry: 05/2016. b) Lot #: C409652
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
- 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
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