The Recall Desk
LowFDA (Drugs)·D-0419-2018·Announced 2018-02-07

Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 20 mg tablets because stability testing revealed out-of-specification total degradation impurities.

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 Atorvastatin Calcium Tablets 20 mg, prescription only, manufactured in Srikakulam, India. The recall involves 90-count and 500-count bottles, specifically NDC 55111-122-05. The affected lots are T600126 (manufactured March 2018), T600202 (manufactured May 2018), and T600247 (manufactured May 2018). The total quantity recalled is 28,941 bottles of the 90-count size and 2,928 bottles of the 500-count size.

The recall was initiated because the product failed impurities and degradations specifications. Specifically, out-of-specification results were observed for Total Degradation Impurities during stability testing. The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.

The product was distributed nationwide. Patients currently taking these specific lots of Atorvastatin Calcium should contact their healthcare provider or pharmacist for guidance on alternative treatment options. Consumers should not return the medication to the pharmacy unless instructed to do so by a healthcare professional.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
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 (7)

  • Lot numbers: a) T600126
  • 3/2018
  • T600202 and T600247 5/2018
  • b) T600126
  • T600202
  • and T600247
  • 5/2018

UPCs (1)

  • 0355111123903

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same brand · ATORVASTATIN CALCIUM

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

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Same hazard · impurity

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