US Drug Recall Register
Class III · Low risk Terminated Initiated Sep 22, 2016 (10 years ago)

PARICALCITOL Capsules

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

PARICALCITOL Capsules, 2 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 0093-7657-56.

Recalling firm
Teva Pharmaceuticals USA
NDC code
0093-7657-56
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0110-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Paricalcitol recalls

See all
Class III · Low risk Terminated

Paricalcitol Capsules

Reason Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.

Amerisource Health Services NDC 60687-106-25 D-0009-2017
Class III · Low risk Terminated

PARICALCITOL Capsules

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

Teva Pharmaceuticals USA NDC 0093-7658-56 D-0111-2017
Class III · Low risk Terminated

PARICALCITOL Capsules

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

Teva Pharmaceuticals USA NDC 0093-7656-56 D-0109-2017
Class III · Low risk Terminated

Zemplar

Reason Failed Content Uniformity Specifications

AbbVie Inc. NDC 0074-4317-30 D-0833-2016
Class II · Moderate risk Terminated

Paricalcitol Capsules

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

Teva Pharmaceuticals USA NDC 0093-7656-56 D-0774-2016