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
Reported: January 17, 2018 Initiated: December 12, 2017 #D-0210-2018
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
Details
- Recalling Firm
- Woodfield Pharmaceutical, LLC
- Units Affected
- 15,707 bottles
- Distribution
- Texas
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Woodfield Pharmaceutical, LLC. Units affected: 15,707 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0210-2018.
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