The Recall Desk
LowFDA (Drugs)·D-1375-2015·Announced 2015-09-02

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's Laboratories is recalling 984 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 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 984 bottles of Amlodipine Besylate and Atorvastatin Calcium Tablets, 2.5 mg/40 mg, 30 Count Bottles. The product is identified by NDC 43598-317-30, Lot # C402341, and an expiration date of 08/2015. The recall was initiated because the atorvastatin component of the tablets is subpotent, meaning it does not contain the full labeled amount of the active ingredient.

The affected product was distributed nationwide in the United States. The tablets are prescription-only medications 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 product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options or replacement medication.

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
984

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 #: C402341
  • Expiry: 08/2015

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

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · subpotent drug

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