EDETATE CALCIUM DISODIUM recalled over sterility concerns

Recall date

July 24, 2015

Source

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

Official notice title

JD & SN Inc., dba Moses Lake Professional Pharmacy recalls EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL syringe, Rx only, JD & SN Inc, DBA Mo…

Recall number

D-0077-2016

FDA classification

Class II

Brand / firm

JD & SN Inc., dba Moses Lake Professional Pharmacy

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314