Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
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.
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.
Reason Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Reason Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Reason Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Reason Failed Content Uniformity Specifications
Reason Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
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