Recalls / Class II
Class IID-1484-2022
Product
Acetaminophen Oral Solution 160 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 0904-6738-70
- Affected lot / code info
- Lot# 20078A, 20083A EXP Aug. 2022; 20092A, EXP Sep. 2022; 21058A, 21048C, EXP May. 2023; 21063C, EXP Jun. 2023; 21093B, EXP Sep. 2023; 22001C, EXP Jan. 2024; 22017A, EXP Mar. 2024.
Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recalling firm
- Firm
- Plastikon Healthcare LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3780 Greenway Cir, N/A, Lawrence, Kansas 66046-5440
Distribution
- Quantity
- 290,270 cups
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-07
- FDA classified
- 2022-09-06
- Posted by FDA
- 2022-09-14
- Terminated
- 2025-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1484-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.