FDA recall D-0774-2016

Product

Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, 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

2016-02-05

Report date

2016-03-23

Termination date

2017-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2016