CLASS II Drug recall · Reported 14 Sep 2022 · FDA Enforcement Report
Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup recalled
Plastikon Healthcare is recalling Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup, distributed nationwide in the US. The recall was initiated on 7 Jun 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1490-2022
- FDA event ID
- 90398
- Recalling firm
- Plastikon Healthcare, Lawrence, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2022
- FDA classified
- 6 Sep 2022
- Reported
- 14 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 7 Jun 2022 | Recall initiated by company | |
| 6 Sep 2022 | Classified by FDA | +91 days |
| 14 Sep 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product as listed by the FDA
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Which lots are affected?
Lot # 20091A, EXP Sep. 2022; 20104A, EXP Nov. 2022; 21013A, EXP Feb. 2023; 21041A, EXP Apr. 2023; 21102A, EXP Sep. 2023; 21121A, 21127A, EXP Nov. 2023; 22003A, 22007A, EXP Jan. 2024; 22016A, EXP Mar. 2024
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 90398This product is part of a recall event; the main page for the event is Diphenhydramine HCl Oral Solution 12.5 mg / cup recalled.
More recalls from Plastikon Healthcare
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Correctdose Children's Cough & Chest Congestion DM recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Correctdose Children's Allergy Relief recalled by Plastikon Healthcare | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Guaifenesin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI HoldingsGuaifenesin And Codeine Phosphate | PAI Holdings | Potency & Assay | OH |
| Drug | CLASS II | Guaifenesin Oral Solution, 300 mg/, Sugar Free/Alcohol Free recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rompe Pecho Ex Expectorant recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS III | Mucinex DM (guaifenesin 600mg recalled by Reckitt BenckiserMucinex Dm | Reckitt Benckiser | Packaging Defects | Nationwide |