D-1490-2022 Class II Terminated
FDA drug recall D-1490-2022 was initiated by Plastikon Healthcare LLC on Jun 7, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. The recall status is terminated (terminated Jun 25, 2025). Affected quantity: 280,500 cups.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 14, 2022
- Initiation Date
- Jun 7, 2022
- Termination Date
- Jun 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280,500 cups
Product description
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
Reason for recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Distribution pattern
Distributed Nationwide in the USA
Code information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1490-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026