FDA recall D-0914-2017

Product

VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Reason for recall

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-02-17

Report date

2017-06-21

Termination date

2017-06-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0914-2017