FDA recall D-0219-2017

Product

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

Reason for recall

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

Distribution

TX

Key facts

Status

Terminated

Initiation date

2016-07-25

Report date

2016-12-28

Termination date

2017-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Conway, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0219-2017