FDAClass IIJanuary 17, 2018

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL recall: Sterility Concern

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

Why was Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 08616; Exp. 07/18

Product
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX…
Recalling firm
Woodfield Pharmaceutical, LLC
Quantity
15,707 bottles
Distribution
Texas
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls