FDA recall D-0210-2018

Product

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16

Reason for recall

Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia

Distribution

Texas

Key facts

Status

Terminated

Initiation date

2017-12-12

Report date

2018-01-17

Termination date

2020-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0210-2018