Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Sorbugen Nr
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.
Affected NDC
52083-0660-16
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 |
|---|---|---|---|---|
| Sorbugen dextromethorphan hydrobromide, glycerol guaiacolate NDC 52083-0660 |
DEXTROMETHORPHAN HYDROBROMIDE 15 mg/7.5mL; GUAIFENESIN 150 mg/7.5mL | Syrup Oral |
Kramer Novis | OTC |
- Recalling firm
- Pharma-Natural Inc.
- NDC code
- 52083-660-16
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1505-2019 · 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 Pharma-Natural Inc.
All 2019 recalls
Class II · Moderate risk
Workvie Instant Pain Relieving Roll On
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Neogen-D
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Tusslin
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Dayma SUPER FORTE XL10
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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