Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Ritussin DM Dextromethorphan Hydrobormide
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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
Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
Affected NDC
53807-4090-04
Compare with the code on your package — it is the most precise check available.
Drug: Guaifenesin
- Recalling firm
- RIJ Pharmaceutical LLC
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0849-2018 · 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.
Other Guaifenesin recalls
See all
Class II · Moderate risk
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class III · Low risk
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Other recalls by RIJ Pharmaceutical LLC
All 2018 recalls
Class II · Moderate risk
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Gericare Diocto Liquid
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
SDA Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Geritrex Senna Syrup
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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