Recall Enforment Report D-0719-2016

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 11-04-2015 for the product Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30 The product was recalled due to failed tablet/capsule specifications: product recalled due to reports of breakage and leakage of paricalcitol capsules.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0719-201611-04-201502-24-2016Class III9,155 bottlesParicalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.Terminated
D-0720-201611-04-201502-24-2016Class III4383 bottlesParicalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.Terminated
D-0721-201611-04-201502-24-2016Class III11,123 bottlesParicalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
55111-663Paricalcitol ParicalcitolCapsule, Liquid FilledOralDr. Reddy's Laboratories LimitedHuman Prescription Drug
55111-664Paricalcitol ParicalcitolCapsule, Liquid FilledOralDr. Reddy's Laboratories LimitedHuman Prescription Drug
55111-665Paricalcitol ParicalcitolCapsule, Liquid FilledOralDr. Reddy's Laboratories LimitedHuman Prescription Drug