FDA-Drug2016-03-23Class II

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.

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
30,891 Bottles
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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.

Official notice

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

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