FDA recall D-0109-2017

Product

PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.

Reason for recall

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-09-22

Report date

2016-10-26

Termination date

2017-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0109-2017