Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
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 Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Reason Failed Content Uniformity Specifications
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