The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0720-2016·Announced 2016-02-24

Dr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage

Dr. Reddy's Laboratories is recalling Paricalcitol capsules due to reports of breakage and leakage. The recall covers 4,383 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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 indicates that use of or exposure to the product is not likely to cause adverse health consequences. The issue is physical breakage and leakage rather than a chemical or biological hazard.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Paricalcitol Capsules, 2 mcg, 30 capsules per bottle. The recall was initiated due to reports of breakage and leakage of the capsules.

The affected product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in Bachupally, India. The recall involves 4,383 bottles distributed nationwide. Specific lot numbers include C404653, C404654, C404655 (Exp 05/2016) and C505010 (Exp 06/2017).

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. 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.

The recalled product

Product
PARICALCITOL (PARICALCITOL)
Brand
PARICALCITOL
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
4,383

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 (6)

  • Lot #s: C404653
  • C404654
  • C404655
  • Exp 05/2016
  • C505010
  • Exp 06/2017

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 →

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