# FDA recall D-1388-2012

> **Abbott Laboratories** · Class II · drug recall initiated 2012-05-14.

## Product

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

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1388-2012
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-14
- **Report date:** 2012-06-27
- **Termination date:** 2012-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Abbott Park, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1388-2012

## Citation

> AI Analytics. FDA recall D-1388-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1388-2012. Source: US FDA. Licensed CC0.

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