D-1489-2022 Class II Terminated
FDA drug recall D-1489-2022 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: 349,100 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
- 349,100 cups
Product description
Diphenhydramine HCl Oral Solution, 25 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 0904-6741-72
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 # 20065A, EXP Jun. 2022; 20068A, 20070A, EXP Jul. 2022; 20097A, 20098A, EXP Oct. 2022; 21055A, EXP May. 2023; 21083A, EXP Jul. 2023; 21091A, EXP Aug. 2023; 21112A, EXP Oct. 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1489-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026