GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL — Class II drug recall D-1491-2022
Terminated recall by Plastikon Healthcare LLC, reported 2022-09-14, distributed nationwide. CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not ad
| Recall number | D-1491-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Plastikon Healthcare LLC, Lawrence, KS, United States |
| Recall initiated | 2022-06-07 |
| Classified | 2022-09-06 |
| Reported by FDA | 2022-09-14 |
| Terminated | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 246,200 cups |
| Reason classes | cgmp |
| NDC | 00904-6980-72 |
| Lot numbers | 20091A, 20104A, 21017A, 21034A, 21036A, 21092A, 21105A, 21106A, 21134A, 22007B, 22012A, 22016B |
| Expiration dates | 2022-09-20, 2022-11-20, 2023-02-20, 2023-03-20, 2023-08-20, 2023-10-20, 2023-12-20, 2024-01-20, 2024-02-20, 2024-03-20 |
Product
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 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 0904-6980-72
Reason for recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1491-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.