FDA Drug Recalls

Recalls / Class II

Class IID-1033-2016

Product

Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01

Affected lot / code info
Lot #:565003A, Exp.01 Aug 2017

Why it was recalled

Presence of Particulate Matter: Cardboard

Recalling firm

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

Distribution

Distribution pattern
Nationwide

Timeline

Recall initiated
2016-05-06
FDA classified
2016-06-15
Posted by FDA
2016-06-22
Terminated
2018-09-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1033-2016. 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