FDA recall D-0641-2017

SCA Pharmaceuticals · Class I · drug

Product

Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59

Reason for recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Distribution

U.S. Nationwide

Key facts

Status
Terminated
Initiation date
2017-02-03
Report date
2017-04-12
Termination date
2017-10-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2017