Drug product
Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8
D-0857-2020
Product summary
- Event
- Event 84857
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5472 bottles
- Official record key
drug-enforcement:D-0857-2020
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