FDA Drug Recalls

Recalls / Class II

Class IID-106-2013

Product

Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01

Affected lot / code info
Lot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013

Why it was recalled

Presence of Particulates; may contain glass particles

Recalling firm

Firm
Hospira Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579

Distribution

Quantity
361,600/1-mL ampules
Distribution pattern
Nationwide

Timeline

Recall initiated
2012-10-25
FDA classified
2012-12-28
Posted by FDA
2013-01-09
Terminated
2014-10-15
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-106-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls