Codeine-guaifenesin Solution
FDA Recall NDC 58657-500
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Codeine-guaifenesin (NDC 58657-500). A significant event, classified as Class II, was initiated on Dec 12, 2017 by Method Pharmaceuticals, Llc. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2017 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Dec 12, 2017
Jan 17, 2018
15,707 bottles
Recall Profile & Regulatory Data
Event ID
78757
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Woodfield Pharmaceutical, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Texas
Termination Date
Jan 24, 2020
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
Batch or Lot Expiration Information
Lot# Lot: 08616; Exp. 07/18
Affected Packages Involved in this Recall
58657-500-04Product
58657-500-16Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
