Recalls / Class II
Class IID-0869-2022
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.
- Affected lot / code info
- Lot: 20040A, EXP May 2022
Why it was recalled
CGMP Deviations: Failure to properly investigate failed microbial testing.
Recalling firm
- Firm
- Plastikon Healthcare LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3780 Greenway Cir, N/A, Lawrence, Kansas 66046-5440
Distribution
- Quantity
- 121,800 Unit Dose cups
- Distribution pattern
- Distributed in Indiana for further distribution in the USA.
Timeline
- Recall initiated
- 2022-03-24
- FDA classified
- 2022-05-13
- Posted by FDA
- 2022-05-25
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0869-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.