Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
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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