FDA recall D-1388-2012

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

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

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