Acetaminophen Oral Solution 160 mg Recalled for Manufacturing Control Deviations
Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II drug recall for manufacturing control deviations (CGMP deviations) with no reported illnesses or injuries. It qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Plastikon Healthcare LLC has recalled Acetaminophen Oral Solution 160 mg/5 mL, packaged for institutional use only, in 5 mL cups. Approximately 290,270 cups are affected.
The recall was issued due to CGMP deviations—the products were manufactured under conditions in which manufacturing processes were not adequately controlled.
The product was distributed nationwide throughout the USA. Multiple lots are affected with expiration dates ranging from August 2022 through January 2024. Healthcare facilities and institutions with this product should discontinue use and contact Plastikon Healthcare LLC for return or replacement instructions.
The recalled product
- 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
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Oral Solution
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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.
Distribution
Distributed nationwide across the United States.
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