Acetaminophen Oral Solution Recalled Due to Manufacturing Quality Control Failure
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.
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 FDA Class II recall involves a manufacturing failure to properly investigate failed microbial testing, constituting a risk-of-harm product. Per the rubric, this meets the 'High' severity criterion for products where injury has not yet been reported but significant quality control failure creates contamination risk.
Plain-English summary
The FDA has classified the recall of Acetaminophen Oral Solution, USP 650 mg/20.3 mL, as a Class II recall. The product is being recalled due to Current Good Manufacturing Practice (CGMP) deviations involving failure to properly investigate failed microbial testing.
The affected product includes 121,800 unit dose cups (Lot 20040A, expiration May 2022) distributed by Major Pharmaceuticals (Livonia, Michigan, NDC 0904-6820-76). The product was initially distributed in Indiana for further distribution throughout the United States. The medication is labeled for institutional use only.
The manufacturing failure to properly investigate failed microbial tests creates a potential risk of microbial contamination. Consumers and healthcare facilities with this product should consult their pharmacist or healthcare provider regarding appropriate disposal or return of the affected medication.
The recalled product
- Product
- Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
- Manufacturer
- Plastikon Healthcare LLC
- Hazard
- microbial-contamination
- 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 (2)
- Lot: 20040A
- EXP May 2022
Distribution
Distribution scope not specified by the agency.
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