Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant (Codeine Phosphate and Guaifenesin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
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
Affected NDC
58657-0500-16
Compare with the code on your package — it is the most precise check available.
Drug: Guaifenesin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Codeine-Guaifenesin Codeine Phosphate and Guaifenesin NDC 58657-0500 |
CODEINE PHOSPHATE 10 mg/5mL; GUAIFENESIN 100 mg/5mL | Solution Oral |
Method Pharmaceuticals, LLC | OTC · CV |
- Recalling firm
- Woodfield Pharmaceutical, LLC
- NDC code
- 58657-500-16
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0210-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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All microbial contamination recalls
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