CLASS II Drug recall · Reported 27 Jun 2012 · FDA Enforcement Report
Zemplar (paricalcitol) Injection, 5 mcg/mL recalled
Abbott Laboratories is recalling Zemplar (paricalcitol) Injection, 5 mcg/mL in multi-dose vials, 25 vial, distributed nationwide in the US. The recall was initiated on 14 May 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1388-2012
- FDA event ID
- 61878
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
- Brand
- Zemplar
- Manufacturer
- AbbVie Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 May 2012
- FDA classified
- 18 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 14 May 2012 | Recall initiated by company | |
| 18 Jun 2012 | Classified by FDA | +35 days |
| 27 Jun 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Zemplar (paricalcitol) Injection, 5 mcg/mL in multi-dose vials, 25 vial recalled?
Yes. Abbott Laboratories recalled Zemplar (paricalcitol) Injection, 5 mcg/mL in multi-dose vials, 25 vial on 14 May 2012. The recall is Class II and its status is Terminated. Recall number D-1388-2012.
Why was it 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.
Which lots are affected?
Lot #: 11-122-DK, Exp 10/13
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Paricalcitol recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Paricalcitol Capsules, 1 mcg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Paricalcitol Capsules, 4 mcg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Paricalcitol Capsules, 2 mcg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Paricalcitol Capsules, 1 mcg recalled by Amerisource Health Services | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Zemplar (paricalcitol) capsules, 1 mcg recalled by AbbVieZemplar | AbbVie | Other | Nationwide |