FDA recall D-0719-2016

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

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.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-11-04
Report date
2016-02-24
Termination date
2017-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0719-2016