Recalls / Class II

Class IID-1486-2022

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

Affected lot / code info

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.

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

3,507,740 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-1486-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.