Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactur...
FDA Recall #D-0210-2018 — Class II — December 12, 2017
Product Description
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
Recalling Firm
Woodfield Pharmaceutical, LLC — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15,707 bottles
Distribution
Texas
Code Information
Lot: 08616; Exp. 07/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated