Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
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: 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 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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