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
Reported: September 14, 2022 Initiated: June 7, 2022 #D-1485-2022
Product Description
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
Reason for Recall
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Details
- Recalling Firm
- Plastikon Healthcare LLC
- Units Affected
- 848,500 cups
- Distribution
- Distributed Nationwide in the USA
- Location
- Lawrence, KS
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Plastikon Healthcare LLC. Units affected: 848,500 cups.
Why was this product recalled? ▼
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2022. Severity: Moderate. Recall number: D-1485-2022.
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