FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
Woodfield Pharmaceutical, LLC
UPC
Lot: 08616; Exp. 07/18

Units Affected

15,707 bottles

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