Class III · Low risk
Paricalcitol Capsules
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Zemplar (paricalcitol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
0074-1658-05
Compare with the code on your package — it is the most precise check available.
Drug: Paricalcitol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zemplar Paricalcitol NDC 00074-1658 |
5 ug/mL | Injection, Solution Intravenous |
AbbVie Inc. | Rx |
- Recalling firm
- Abbott Laboratories
- NDC code
- 0074-1658-05
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1388-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Paricalcitol recalls
See all
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
Zemplar (paricalcitol)
Failed Content Uniformity Specifications
Other recalls by Abbott Laboratories
All 2012 recalls
Class II · Moderate risk
Synthroid (Levothyroxine Sodium)
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
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