Drug product
Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA
D-0858-2020
Product summary
- Event
- Event 84857
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1176 bottles b) 6,216 bottles
- Official record key
drug-enforcement:D-0858-2020
Official wording
Reason: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Code information: Lot #: 193005, Exp. Date 08/21
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets