Docusate Oral 10 mg/mL Oral Syringe recalled over sterility concerns

Recall date

July 25, 2016

Source

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

Official notice title

US Compounding Inc recalls Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringe…

Recall number

D-0219-2017

FDA classification

Class I

Brand / firm

US Compounding Inc

Sold / distributed

TX

Why it was recalled

Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia

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

Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR