Codeine-Guaifenesin Oral Solution mg/ Antitussive Expectorant recalled over sterility concerns
- Recall date
- December 12, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Woodfield Pharmaceutical, LLC recalls Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmac…
- Recall number
- D-0210-2018
- FDA classification
- Class II
- Brand / firm
- Woodfield Pharmaceutical, LLC
- Sold / distributed
- Texas
Why it was recalled
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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