Why it was recalled
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1486-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 7, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 3,507,740 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Plastikon Healthcare LLC
Original FDA data
Every field from FDA enforcement report D-1486-2022, exactly as published.
Show all FDA fields
- City
- Lawrence
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 90398
- Address
- 3780 Greenway Cir
- 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.
- Postal code
- 66046-5440
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1486-2022
- Classification
- Class II
- Recalling firm
- Plastikon Healthcare LLC
- Product quantity
- 3,507,740 cups
- Termination date
- Jun 25, 2025
- Reason for recall
- CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 7, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 6, 2022