Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent; sodium benzoate preservative
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Released product should have been rejected.
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Reason Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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