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.
Reported: May 25, 2022 Initiated: March 24, 2022 #D-0869-2022
Product Description
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.
Reason for Recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
Details
- Recalling Firm
- Plastikon Healthcare LLC
- Units Affected
- 121,800 Unit Dose cups
- Distribution
- Distributed in Indiana for further distribution in the USA.
- Location
- Lawrence, KS
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Plastikon Healthcare LLC. Units affected: 121,800 Unit Dose cups.
Why was this product recalled? ▼
CGMP Deviations: Failure to properly investigate failed microbial testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2022. Severity: Moderate. Recall number: D-0869-2022.
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