Drug & medication recalls Moderate risk

Teva Pharmaceuticals USA recalls Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt…

Recall date
February 5, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0774-2016
FDA classification
Class II
Brand / firm
Teva Pharmaceuticals USA
Sold / distributed
Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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