Class II · Moderate risk
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
National Drug Code
Is NDC 58657-0500-16 recalled?
Codeine-Guaifenesin · 473 mL in 1 BOTTLE (58657-500-16)
Yes — this exact package was recalled
1 FDA recall names the code 58657-0500-16 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Codeine Phosphate and Guaifenesin
- Strength
- CODEINE PHOSPHATE 10 mg/5mL; GUAIFENESIN 100 mg/5mL
- Form
- Solution · Oral
- Labeler
- Method Pharmaceuticals, LLC
- Type
- Human OTC Drug · DEA CV
- Product code
- 58657-0500
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Free recall alerts
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