FDA-Drug2016-10-26Class III

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.

Teva Pharmaceuticals USA
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
32,015 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.

Official notice

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

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