Acetaminophen Oral Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This recall is classified as Moderate because it is based on manufacturing control deviations without reported illnesses or injuries. It represents a precautionary FDA Class II recall where manufacturing processes did not meet adequate quality control standards.
Plain-English summary
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution, 325 mg / 10.15 mL, nationwide. The product is distributed in institutional settings in 10.15 mL cups, packaged 10 cups per tray and 10 trays per carton. A total of 848,500 cups across multiple lot numbers are affected, with expiration dates ranging from June 2022 to March 2024.
The recall was issued because the manufacturing processes were not adequately controlled, which constitutes a CGMP (Current Good Manufacturing Practice) deviation.
The affected product was distributed nationwide to institutional healthcare facilities. Healthcare providers and facilities should immediately discontinue use and distribution of recalled lots.
Patients who received this medication should consult with their healthcare provider about the recall and to discuss alternative treatment options.
The recalled product
- Product
- Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 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 0904-6739-71
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug
- Affected units
- 848,500
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 (20)
- Lot # 20062A
- 20067A
- EXP Jun. 2022
- 20092A
- 20093A
- EXP Sep. 2022
- 20101A
- 21110A
- EXP Oct. 2022
- 20108A
- EXP Nov. 2022
- 21012A
- EXP Jan. 2023
- 21044A
- 21048B
- EXP Apr. 2023
- 21053A
- EXP May. 2023
- 21063B
- 21068B
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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