PlainRecalls
FDA Drug Low Class III Terminated

PARICALCITOL Capsules, 4 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 0093-7658-56.

Reported: October 26, 2016 Initiated: September 22, 2016 #D-0111-2017

Product Description

PARICALCITOL Capsules, 4 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 0093-7658-56.

Reason for Recall

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

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
5,398 bottles
Distribution
Nationwide and Puerto Rico
Location
North Wales, PA

Frequently Asked Questions

What product was recalled?
PARICALCITOL Capsules, 4 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 0093-7658-56.. Recalled by Teva Pharmaceuticals USA. Units affected: 5,398 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 26, 2016. Severity: Low. Recall number: D-0111-2017.