Drug product
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0904-6820-76
D-1486-2022
Product summary
- Event
- Event 90398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,507,740 cups
- Official record key
drug-enforcement:D-1486-2022
Official wording
Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Code information: Lot # 20064A, 20066A, EXP Jun. 2022; 20069A, 20073A, EXP Jul. 2022; 20094A, 20094B, 20095A, 20095B, EXP Sep. 2022; 20103A, EXP Oct. 2022; 20105A, EXP Nov. 2022; 20111A, 20111B, EXP Dec. 2022; 21005A, 21005B, EXP Jan. 2023; 21019A, 21019B, EXP Feb. 2023; 21035A, 21035B, 21038A, EXP Mar. 2023; 21048A, 21048D, EXP Apr. 2023; 21058B, EXP May. 2023; 21063A, 21068A, EXP Jun. 2023; 21084A, EXP Jul. 2023; 21090B, EXP Aug. 2023; 21093A, EXP Sep. 2023; 21124A, 21126A, EXP Nov. 2023; 21136A,20112A, 21122A,21122C, 20112B, EXP Dec. 2023; 22001A, 22001D, 22006B, 22006C, EXP Jan. 2024; 22010A, 22011A, 22011B, EXP Feb. 2024; 22014A, 22015A, 22021A, EXP Mar. 2024.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations