SCA Pharmaceuticals recalls Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Ro…

Recall date

February 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0641-2017

FDA classification

Class I

Brand / firm

SCA Pharmaceuticals

Sold / distributed

U.S. Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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