Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories L...

FDA Recall #D-0719-2016 — Class III — November 4, 2015

Recall #D-0719-2016 Date: November 4, 2015 Classification: Class III Status: Terminated

Product Description

Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30

Reason for Recall

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

Recalling Firm

Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

9,155 bottles

Distribution

Nationwide

Code Information

Lot #s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp 07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016; C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated